Clinical trial NCT02807857: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Official title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure (CHF)
Keywords: low-interventional observational study,
CHF,
heart failure,
primary care,
ESC guidelines,
Europe,
NT-proBNP,
reduced ventricular ejection fraction (EF),
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 1415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

Detailed description: In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \< or = 40%) and NT-proBNP level \> or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent and accept study procedures and time schedule.
* Age ≥ 18 years.
* Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).
* Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.

Exclusion Criteria:

* Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
* Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.
* Cancer or other significant co-morbidities implying that the patient's condition is unstable.
* Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR \< 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
* Patients who are primarily managed and regularly followed-up by a cardiologist for their HF
* Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months.

Primary outcomes:
measure: Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)
timeFrame: Baseline (Visit 1)
measure: Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose
timeFrame: Month 6
Secondary outcomes:
measure: Duration of Heart Failure
timeFrame: Baseline (Visit 1)
measure: Number of Patients With Current Use of Concomitant Compound
timeFrame: Baseline (Visit 1)
measure: Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2
timeFrame: 6 months (Visit 2)
measure: Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics
timeFrame: 6 months
measure: Number of Patients With Different NT-proBNP Level Categories
timeFrame: One measurement in all consecutive patients at baseline (Visit 1)
measure: Percentages of Clinically Stable Patients
timeFrame: Baseline (Visit 1)
measure: Number of Patients by Cardiologist Prescription Practice Per Country/Region
timeFrame: 6 months
measure: Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline
timeFrame: 10 months
measure: Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
timeFrame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)
timeFrame: Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)
measure: Number of Patients in Different Living Conditions
timeFrame: Baseline (Visit 1)
measure: Number of Patients in Different Employment Status
timeFrame: Baseline (Visit 1)
measure: Number of Patients With Smoking Status
timeFrame: Baseline (Visit 1)
measure: Number of Patients From Different Geographical Regions
timeFrame: Baseline (visit 1)
measure: Number of Patients With Health Insurance Status
timeFrame: Baseline (Visit 1)
measure: Number of Patients at Different Educational Level
timeFrame: Baseline (Visit 1)
measure: Number of Patients Per Primary Etiology of Heart Failure
timeFrame: Baseline (Visit 1)
measure: Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study
timeFrame: Baseline (Visit 1), 6 months, 10 months
measure: Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities
timeFrame: Baseline (Visit 1)
measure: Mean Dose of Previously Taken and Current Use of Concomitant Medications
timeFrame: Baseline (Visit 1), 6 months, 10 months
measure: Number of Heart Failure (HF) Treatment Combinations
timeFrame: Baseline (Visit 1)
measure: Duration of Treatment With Device Type
timeFrame: Baseline (Visit 1)
measure: Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds
timeFrame: Baseline (Visit 1)
measure: Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region
timeFrame: Baseline (Visit 1)
Other outcomes:
Locations:
city: Binkom
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Gozee
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Linkebeek
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Oostham
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Zichem
country: Belgium
facility: Novartis Investigative Site
state: BEL
city: Aarschot
country: Belgium
facility: Novartis Investigative Site
city: Alveringem
country: Belgium
facility: Novartis Investigative Site
city: Boezinge
country: Belgium
facility: Novartis Investigative Site
city: Bruxe
country: Belgium
facility: Novartis Investigative Site
city: Buggenhout, Belgium
country: Belgium
facility: Novartis Investigative Site
city: Deinze
country: Belgium
facility: Novartis Investigative Site
city: Deurne
country: Belgium
facility: Novartis Investigative Site
city: Diksmuide
country: Belgium
facility: Novartis Investigative Site
city: Ezemaal-Neerwinden
country: Belgium
facility: Novartis Investigative Site
city: Hasselt, Belgium
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Herzele
country: Belgium
facility: Novartis Investigative Site
city: Kluisbergen
country: Belgium
facility: Novartis Investigative Site
city: Landen
country: Belgium
facility: Novartis Investigative Site
city: Leefdaal
country: Belgium
facility: Novartis Investigative Site
city: Linkebeek
country: Belgium
facility: Novartis Investigative Site
city: Lommel
country: Belgium
facility: Novartis Investigative Site
city: Maasmechelen
country: Belgium
facility: Novartis Investigative Site
city: Mont sur Marchienne
country: Belgium
facility: Novartis Investigative Site
city: Nazareth
country: Belgium
facility: Novartis Investigative Site
city: OOsteeklo
country: Belgium
facility: Novartis Investigative Site
city: Oostende
country: Belgium
facility: Novartis Investigative Site
city: Oudenaarde
country: Belgium
facility: Novartis Investigative Site
city: Saint-Medard
country: Belgium
facility: Novartis Investigative Site
city: Stoumont
country: Belgium
facility: Novartis Investigative Site
city: Tessenderlo
country: Belgium
facility: Novartis Investigative Site
city: Thuilles
country: Belgium
facility: Novartis Investigative Site
city: Tielt-Winge
country: Belgium
facility: Novartis Investigative Site
city: Tremelo
country: Belgium
facility: Novartis Investigative Site
city: Vilvoorde
country: Belgium
facility: Novartis Investigative Site
city: Waregem
country: Belgium
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Visnjevac
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Bizovac
country: Croatia
facility: Novartis Investigative Site
city: HRV
country: Croatia
facility: Novartis Investigative Site
city: HRV
country: Croatia
facility: Novartis Investigative Site
city: HRV
country: Croatia
facility: Novartis Investigative Site
city: HRV
country: Croatia
facility: Novartis Investigative Site
city: Krasica
country: Croatia
facility: Novartis Investigative Site
city: Osijek
country: Croatia
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Slavonski Brod
country: Croatia
facility: Novartis Investigative Site
city: Velika Kopanica
country: Croatia
facility: Novartis Investigative Site
city: Viskovo
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Nicosia
country: Cyprus
facility: Novartis Investigative Site
city: Nicosia
country: Cyprus
facility: Novartis Investigative Site
city: Præstø
country: Denmark
facility: Novartis Investigative Site
city: Skive
country: Denmark
facility: Novartis Investigative Site
city: Someru
country: Estonia
facility: Novartis Investigative Site
state: EST
city: Paide
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facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Arras
country: France
facility: Novartis Investigative Site
city: Bersee
country: France
facility: Novartis Investigative Site
city: Breteuil Sur Seine
country: France
facility: Novartis Investigative Site
city: Cannes
country: France
facility: Novartis Investigative Site
city: Chantepie
country: France
facility: Novartis Investigative Site
city: Colombiers
country: France
facility: Novartis Investigative Site
city: Coursan
country: France
facility: Novartis Investigative Site
city: Erquy
country: France
facility: Novartis Investigative Site
city: La Seyne-sur-Mer
country: France
facility: Novartis Investigative Site
city: Laval
country: France
facility: Novartis Investigative Site
city: Les Pennes Mirabeau
country: France
facility: Novartis Investigative Site
city: Negrepelisse
country: France
facility: Novartis Investigative Site
city: Orthez
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rosiers d'Egleton
country: France
facility: Novartis Investigative Site
city: Salles
country: France
facility: Novartis Investigative Site
city: Six Fours
country: France
facility: Novartis Investigative Site
city: St orens de Gameville
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Balatonkeresztur
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Csongrad
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Felsorajk
country: Hungary
facility: Novartis Investigative Site
city: Hosszuheteny
country: Hungary
facility: Novartis Investigative Site
city: Kecskemet
country: Hungary
facility: Novartis Investigative Site
city: Korondi
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
city: Szabadsag
country: Hungary
facility: Novartis Investigative Site
city: Szeged-Szoreg
country: Hungary
facility: Novartis Investigative Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Zakanyszek
country: Hungary
facility: Novartis Investigative Site
city: Beer Sheva
country: Israel
facility: Novartis Investigative Site
city: Grumello Del Monte
country: Italy
facility: Novartis Investigative Site
state: BG
city: Gatteo
country: Italy
facility: Novartis Investigative Site
state: FC
city: Jelgava
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
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facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Klaipeda
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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facility: Novartis Investigative Site
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country: Lithuania
facility: Novartis Investigative Site
city: Xaghra
country: Malta
facility: Novartis Investigative Site
state: Gozo
city: Xewkija
country: Malta
facility: Novartis Investigative Site
state: Gozo
city: Rabat
country: Malta
facility: Novartis Investigative Site
city: Flisa
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facility: Novartis Investigative Site
city: Hamar
country: Norway
facility: Novartis Investigative Site
city: Honefoss
country: Norway
facility: Novartis Investigative Site
city: Kirkenær
country: Norway
facility: Novartis Investigative Site
city: Lierskogen
country: Norway
facility: Novartis Investigative Site
city: Loten
country: Norway
facility: Novartis Investigative Site
city: Lørenskog
country: Norway
facility: Novartis Investigative Site
city: Noetteroey
country: Norway
facility: Novartis Investigative Site
city: Ostereidet
country: Norway
facility: Novartis Investigative Site
city: Skien
country: Norway
facility: Novartis Investigative Site
city: Chelm
country: Poland
facility: Novartis Investigative Site
state: POL
city: Kartuzy
country: Poland
facility: Novartis Investigative Site
state: POL
city: Warszawa
country: Poland
facility: Novartis Investigative Site
state: POL
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bielawa
country: Poland
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Dzierzoniow
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Miasteczko Slaskie
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wielen
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zgierz
country: Poland
facility: Novartis Investigative Site
city: Seixal
country: Portugal
facility: Novartis Investigative Site
state: Bairro Novo
city: Cantanhede
country: Portugal
facility: Novartis Investigative Site
city: Leca da Palmeira
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Oeiras
country: Portugal
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Ufa
country: Russian Federation
facility: Novartis Investigative Site
city: Vladivostok
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Ivancna Gorica
country: Slovenia
facility: Novartis Investigative Site
city: Kranj
country: Slovenia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Pesnica pri Mariboru
country: Slovenia
facility: Novartis Investigative Site
city: Slovenske Konjice
country: Slovenia
facility: Novartis Investigative Site
city: Spodnji Duplek
country: Slovenia
facility: Novartis Investigative Site
city: Vrhnika
country: Slovenia
facility: Novartis Investigative Site
city: Zalec
country: Slovenia
facility: Novartis Investigative Site
city: Cambre
country: Spain
facility: Novartis Investigative Site
state: A Coruna
city: Porto do Son
country: Spain
facility: Novartis Investigative Site
state: A Coruña
city: Petrer
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: El Parador De Las Hortichiuela
country: Spain
facility: Novartis Investigative Site
state: Almeria
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: El canaveral
country: Spain
facility: Novartis Investigative Site
state: Caceres
city: Puerto Real
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Burriana
country: Spain
facility: Novartis Investigative Site
state: Castellon
city: Alcudia
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Telde
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De Gran Canaria
city: Parla
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: A Estrada
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Monteporeiro
country: Spain
facility: Novartis Investigative Site
state: Pontevedra
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Coruna
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Panxon
country: Spain
facility: Novartis Investigative Site
Study officials:
References: