Clinical trial NCT01067859: A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients 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 Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Heart Failure
Keywords: Heart Failure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 5
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 ovariectomy, 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: Pulmonary Capillary Wedge Pressure
timeFrame: 8 hours
Secondary outcomes:
measure: Cardiac index (CI)
timeFrame: 8 hours and 48 hours
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Follow up (after 30+5 days)
measure: Right atrial pressure (RAP)
timeFrame: 8 hours and 48 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Jacksonville
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Quilmes
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Aalst
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Leuven
country: Belgium
city: Creteil
country: France
city: PARIS cedex 10
country: France
city: Toulouse
country: France
city: Bad Krozingen
country: Germany
state: Baden-Württemberg
city: Bad Nauheim
country: Germany
state: Hessen
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Berlin
country: Germany
city: Dublin
country: Ireland
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Mexico D.F.
country: Mexico
state: México
city: México D.F.
country: Mexico
city: Quezon City
country: Philippines
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: