Carvedilol, ivabradine and their combination in patients with heart failure - the CARVIVA-HF study

INTERVENTION: Trade Name: CARVEDILOLO EG*98CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: CARVEDILOL CAS Number: 72956‐09‐3 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 50‐ INN or Proposed INN: IVABRADINE HYDROCHLORIDE CAS Number: 148849‐67‐6 Current Sponsor code: NA Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 15‐ CONDITION: heart failure ; MedDRA version: 14.1 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 14.1 Level: PT Classification code 10063083 Term: Chronic left ventricular failure System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 14.1 Level: LLT Classification code 10007561 Term: Cardiac failure left System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Exercise time at 6 minute walking test Maximal oxygen consumption during exercise Primary end point(s): Exercise time at 6 minute walking test Maximal oxygen consumption during cardiopulmonary exercise test Secondary Objective: 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 SECONDARY OUTCOME: 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 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