Clinical trial NCT01064037: A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Official title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Heart Decompensation
Keywords: Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 62
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: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy
* Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment
* Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload

Exclusion Criteria:

* Acute de-novo heart failure
* Acute myocardial infarction and/or myocardial infarction within 30 days
* Valvular heart disease requiring surgical intervention during the course of the study
* Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
* Primary hypertrophic cardiomyopathy
* Acute inflammatory heart disease, eg, acute myocarditis
* Unstable angina requiring angiography

Primary outcomes:
measure: Dyspnea VAS (using a visual analogue scale)
timeFrame: 8 hours
Secondary outcomes:
measure: Dyspnea assessment (Likert Scale)
timeFrame: up to follow-up (30 - 35 days)
measure: Overall health status assessment (EQ-5D)
timeFrame: up to follow-up (30 - 35 days)
measure: Changes in the dyspnea VAS at other time points
timeFrame: Up to follow up visit
measure: Dyspnea assessment through Likert scale
timeFrame: Up to follow up visit
measure: Overall health status assessment through EQ-5D Health Questionnaire
timeFrame: Up to the follow-up visit
measure: Global clinical assessment by the physician
timeFrame: At 8, 24, and 48 hours
measure: Change in concomitant medications
timeFrame: During the treatment
measure: Safety variables
timeFrame: Up to end of study
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Quebec
country: Canada
city: Brno
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Jyväskylä
country: Finland
city: Turku
country: Finland
city: Dommartin-les-toul
country: France
city: Paris Cedex 04
country: France
city: Paris cedex 13
country: France
city: Paris
country: France
city: POITIERS Cedex
country: France
city: Nürnberg
country: Germany
state: Bayern
city: Melsungen
country: Germany
state: Hessen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Erfurt
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kecskemet
country: Hungary
city: Szekesfehervar
country: Hungary
city: Ballinasloe
country: Ireland
state: Co. Galway
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Haifa
country: Israel
city: Nahariya
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
city: Pontedecimo
country: Italy
state: Genova
city: Casarano
country: Italy
state: Lecce
city: Cotignola
country: Italy
state: Ravenna
city: Bari
country: Italy
city: Ferrara
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Kanazawa
country: Japan
state: Ishikawa
city: Chigasaki
country: Japan
state: Kanagawa
city: Matsumoto
country: Japan
state: Nagano
city: Sunto
country: Japan
state: Shizuoka
city: Tanabe
country: Japan
state: Wakayama
city: Kagoshima
country: Japan
city: Shizuoka
country: Japan
city: Seoul
country: Korea, Republic of
state: Jongno-gu,
city: Seoul
country: Korea, Republic of
state: Songpa-gu
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Olsztyn
country: Poland
city: Szczecin
country: Poland
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Kuils River
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Torrevieja
country: Spain
state: Alicante
city: Majadahonda
country: Spain
state: Madrid
city: El Palmar
country: Spain
state: Murcia
city: Barcelona
country: Spain
city: Harrow
country: United Kingdom
state: London
city: Northampton
country: United Kingdom
state: Northamptonshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: