FindTrial
Sign In

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002520-40-IT
Enrollment
Unknown
Registered
2012-03-05
Start date
2010-10-27
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 mill

Sponsors

CASA DI CURA PRIVATA S.RAFFAELE - PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactDipartimento di Scienze Internistic

IRCCS San Raffaele

giuseppe.rosano@sanraffaele.it0652252310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026