Comparison of the effect of carvedilol, ivabradine and their combination on exercise capacity in patients with heart failure

Conditions: heart failure
MedDRA version: 14.1Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
MedDRA version: 14.1Level: PTClassification code 10063083Term: Chronic left ventricular failureSystem Organ Class: 10007541 - Cardiac disorders
MedDRA version: 14.1Level: LLTClassification code 10007561Term: Cardiac failure leftSystem Organ Class: 10007541 - Cardiac disorders

Registration Number: EUCTR2011-002520-40-IT

Lead Sponsor: CASA DI CURA PRIVATA S.RAFFAELE - PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Heart failure (chronic) 18 years or older not on beta-blockers or if on beta-blockers not receiving adequate ACE-inhibitor dose Exercise capacity >100<600 m
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

recent hospitalisation scheduled hospitalization bradicardia pace-maker with pacing rate > 50 bpm ventricular arrhythmia (Lown class 3 or greater)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Exercise time at 6 minute walking test Maximal oxygen consumption during exercise;Secondary Objective: Quality of life Improvement in quality of life muscle strength Achievement of maximal therapeutic doses;Primary end point(s): Exercise time at 6 minute walking test Maximal oxygen consumption during cardiopulmonary exercise test;Timepoint(s) of evaluation of this end point: 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life Improvement in quality of life muscle strength Achievement of maximal therapeutic doses;Timepoint(s) of evaluation of this end point: 3 months