Clinical trial NCT02064868: Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Official title: A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Heart Failure (AHF)
Keywords: AHF,
RLX030,
SOC,
WHF,
RELAX-AHF-EU
Renal Impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 2666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Detailed description: This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).

Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure ≥ 125 mmHg
* Admitted for Acute Heart Failure (AHF)
* Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening
* eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m\^2

Exclusion Criteria:

* Dyspnea (non-cardiac causes)
* T \> 38.5°C
* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
* Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm\^2 or mean gradient \>50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.
* AHF due to significant arrhythmias
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).

Primary outcomes:
measure: Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5
timeFrame: 5 days
Secondary outcomes:
measure: Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14
timeFrame: 14 days
measure: Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5
timeFrame: 5 days
measure: Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14
timeFrame: 14 days
measure: Length of Index Hospital Stay
timeFrame: 30 Days
measure: Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients
timeFrame: Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days
measure: Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.
timeFrame: Baseline, Day 5, Day 14
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: St. Poelten
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Lodelinsart
country: Belgium
facility: Novartis Investigative Site
city: Mol
country: Belgium
facility: Novartis Investigative Site
city: Mons
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Ronse
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Sliven
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Veliko Tarnovo
country: Bulgaria
facility: Novartis Investigative Site
city: Varazdin
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Decin II
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Karvina-Raj
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Kromeriz
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Melnik
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Pisek
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Svitavy
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Tabor
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Trebic
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Plzen
country: Czechia
facility: Novartis Investigative Site
city: Prague 5
country: Czechia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Marseille cedex 20
country: France
facility: Novartis Investigative Site
state: Bouches Du Rhone
city: Nancy
country: France
facility: Novartis Investigative Site
state: Cedex
city: Abbeville
country: France
facility: Novartis Investigative Site
city: Agen Cedex 9
country: France
facility: Novartis Investigative Site
city: Amiens cedex 1
country: France
facility: Novartis Investigative Site
city: Avignon
country: France
facility: Novartis Investigative Site
city: Belfort
country: France
facility: Novartis Investigative Site
city: Besancon Cedex
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Bron
country: France
facility: Novartis Investigative Site
city: Chalon sur Saône
country: France
facility: Novartis Investigative Site
city: Chambray-lès-Tours
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facility: Novartis Investigative Site
city: Chateauroux
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand
country: France
facility: Novartis Investigative Site
city: Corbeil Essonnes
country: France
facility: Novartis Investigative Site
city: Dunkerque
country: France
facility: Novartis Investigative Site
city: La Seyne sur mer
country: France
facility: Novartis Investigative Site
city: Le Coudray
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex 09
country: France
facility: Novartis Investigative Site
city: Lens
country: France
facility: Novartis Investigative Site
city: Limoges Cedex
country: France
facility: Novartis Investigative Site
city: Lorient Cedex
country: France
facility: Novartis Investigative Site
city: Metz
country: France
facility: Novartis Investigative Site
city: Montauban
country: France
facility: Novartis Investigative Site
city: Montauban
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Mulhouse cedex
country: France
facility: Novartis Investigative Site
city: Nimes Cedex 09
country: France
facility: Novartis Investigative Site
city: Niort
country: France
facility: Novartis Investigative Site
city: Orleans
country: France
facility: Novartis Investigative Site
city: Paris cedex 10
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pau
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Périgueux
country: France
facility: Novartis Investigative Site
city: Rennes Cedex 9
country: France
facility: Novartis Investigative Site
city: Saint Brieuc
country: France
facility: Novartis Investigative Site
city: St Michel
country: France
facility: Novartis Investigative Site
city: St Priest en Jarez Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg Cedex
country: France
facility: Novartis Investigative Site
city: Troyes
country: France
facility: Novartis Investigative Site
city: Vienne
country: France
facility: Novartis Investigative Site
city: Flensburg
country: Germany
facility: Novartis Investigative Site
state: Schleswig Holstein
city: Arnstadt
country: Germany
facility: Novartis Investigative Site
city: Bad Berka
country: Germany
facility: Novartis Investigative Site
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Baden-Baden
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bernburg
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Buchholz in der Nordheide
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dorsten
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Düssledorf
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Eschwege
country: Germany
facility: Novartis Investigative Site
city: Esslingen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Friesoythe
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Gotha
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Guetersloh
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heidenheim
country: Germany
facility: Novartis Investigative Site
city: Hennigsdorf
country: Germany
facility: Novartis Investigative Site
city: Herford
country: Germany
facility: Novartis Investigative Site
city: Hoyerswerda
country: Germany
facility: Novartis Investigative Site
city: Kaufbeuren
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Koeln-Nippes
country: Germany
facility: Novartis Investigative Site
city: Langen
country: Germany
facility: Novartis Investigative Site
city: Lemgo
country: Germany
facility: Novartis Investigative Site
city: Leverkusen
country: Germany
facility: Novartis Investigative Site
city: Lüneburg
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Marl
country: Germany
facility: Novartis Investigative Site
city: Memmingen
country: Germany
facility: Novartis Investigative Site
city: Moenchengladbach
country: Germany
facility: Novartis Investigative Site
city: Muelheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Neumünster
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Neustadt A.d. Aisch
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Ribnitz-Damgarten
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Rotenburg
country: Germany
facility: Novartis Investigative Site
city: Schoenebeck
country: Germany
facility: Novartis Investigative Site
city: Schwabach
country: Germany
facility: Novartis Investigative Site
city: Schwalmstadt
country: Germany
facility: Novartis Investigative Site
city: Singen
country: Germany
facility: Novartis Investigative Site
city: Soest
country: Germany
facility: Novartis Investigative Site
city: Sonneberg
country: Germany
facility: Novartis Investigative Site
city: Speyer
country: Germany
facility: Novartis Investigative Site
city: Stade
country: Germany
facility: Novartis Investigative Site
city: Stadtlohn
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Suhl
country: Germany
facility: Novartis Investigative Site
city: Torgau
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Vechta
country: Germany
facility: Novartis Investigative Site
city: Wesel
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Worms
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
city: Wuppertal
country: Germany
facility: Novartis Investigative Site
city: Wurzen
country: Germany
facility: Novartis Investigative Site
city: Alexandroupolis
country: Greece
facility: Novartis Investigative Site
state: Evros
city: Voula
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Volos
country: Greece
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Kalocsa
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Kistarcsa
country: Hungary
facility: Novartis Investigative Site
city: Mako
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szolnok
country: Hungary
facility: Novartis Investigative Site
city: Reykjavik
country: Iceland
facility: Novartis Investigative Site
city: San Benedetto del Tronto
country: Italy
facility: Novartis Investigative Site
state: AP
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Acquaviva delle Fonti
country: Italy
facility: Novartis Investigative Site
state: BA
city: Altamura
country: Italy
facility: Novartis Investigative Site
state: BA
city: Cassano delle Murge
country: Italy
facility: Novartis Investigative Site
state: BA
city: Treviglio
country: Italy
facility: Novartis Investigative Site
state: BG
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Lodi
country: Italy
facility: Novartis Investigative Site
state: LO
city: Latina
country: Italy
facility: Novartis Investigative Site
state: LT
city: Messina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Cernusco sul Naviglio
country: Italy
facility: Novartis Investigative Site
state: MI
city: Legnano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Matera
country: Italy
facility: Novartis Investigative Site
state: Mount
city: Piacenza
country: Italy
facility: Novartis Investigative Site
state: PC
city: Pordenone
country: Italy
facility: Novartis Investigative Site
state: PN
city: Reggio Emilia
country: Italy
facility: Novartis Investigative Site
state: RE
city: Scandiano
country: Italy
facility: Novartis Investigative Site
state: RE
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Siracusa
country: Italy
facility: Novartis Investigative Site
state: SR
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Orbassano
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Busto Arsizio
country: Italy
facility: Novartis Investigative Site
state: VA
city: Chioggia
country: Italy
facility: Novartis Investigative Site
state: VE
city: Vicenza
country: Italy
facility: Novartis Investigative Site
state: VI
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Vibo Valentia
country: Italy
facility: Novartis Investigative Site
state: VV
city: Pozzuoli
country: Italy
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
state: POL
city: Bilgoraj
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Grodzisk Mazowiecki
country: Poland
facility: Novartis Investigative Site
city: Kielce
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lubin
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Oswiecim
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Tarnobrzeg
country: Poland
facility: Novartis Investigative Site
city: Tarnow
country: Poland
facility: Novartis Investigative Site
city: Walbrzych
country: Poland
facility: Novartis Investigative Site
city: Almada
country: Portugal
facility: Novartis Investigative Site
city: Barreiro
country: Portugal
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Matosinhos
country: Portugal
facility: Novartis Investigative Site
city: Setubal
country: Portugal
facility: Novartis Investigative Site
city: Vila Franca de Xira
country: Portugal
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 4
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: Jud Cluj
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
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country: Romania
facility: Novartis Investigative Site
city: Sibiu
country: Romania
facility: Novartis Investigative Site
city: Tirgoviste
country: Romania
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
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city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
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country: Russian Federation
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city: Gatchina
country: Russian Federation
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city: Izhevsk
country: Russian Federation
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country: Russian Federation
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city: Kazan
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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facility: Novartis Investigative Site
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country: Russian Federation
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country: Russian Federation
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city: Saratov
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Ufa
country: Russian Federation
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city: Vladivostok
country: Russian Federation
facility: Novartis Investigative Site
city: Volgograd
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Zelenograd, Moscow Region
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facility: Novartis Investigative Site
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country: Serbia
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city: Belgrade
country: Serbia
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city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Kamenica
country: Serbia
facility: Novartis Investigative Site
city: Niska Banja
country: Serbia
facility: Novartis Investigative Site
city: Nis
country: Serbia
facility: Novartis Investigative Site
city: Dunajska Streda
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Skalica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
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country: Slovakia
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city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Trencin
country: Slovakia
facility: Novartis Investigative Site
city: Celje
country: Slovenia
facility: Novartis Investigative Site
city: Jesenice
country: Slovenia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Murska Sobota
country: Slovenia
facility: Novartis Investigative Site
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sanlucar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Villamartin
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Toledo
country: Spain
facility: Novartis Investigative Site
state: Castilla La Mancha
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Soria
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Lleida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Terrassa
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Caceres
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De G.C
city: Alcorcon
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Cartagena
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Galdakano
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: La Laguna
country: Spain
facility: Novartis Investigative Site
state: Santa Cruz De Tenerife
city: Manises
country: Spain
facility: Novartis Investigative Site
state: Valencia
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Geneve 14
country: Switzerland
facility: Novartis Investigative Site
city: Liestal
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: Durham
country: United Kingdom
facility: Novartis Investigative Site
state: County Durham
city: Dorchester
country: United Kingdom
facility: Novartis Investigative Site
state: Dorset
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
state: GBR
city: Gateshead
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Barnet
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Dundee
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Swindon
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
citation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.