Heart Rate Reduction in Heart Failure (CARVIVA-HF)
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|ClinicalTrials.gov Identifier: NCT01178528|
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : September 30, 2014
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: ivabradine Drug: "Drug:Carvedilol" and "Drug:Ivabradine" Drug: Carvedilol||Phase 3|
Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes > 3 months Revascularization procedures > 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months
Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.
Efficacy measure Intention to treat Exercise tolerance Quality of life
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||October 2010|
7.5 mg bd
7.5 mg bd
Active Comparator: Carvedilol
up to 25 mg bd
25 mg bd
Experimental: "Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
Drug: "Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
- Exercise Tolerance Assessed by 6 Minute Walking Test [ Time Frame: 3 months ]
Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist.
Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible.
- Maximal Oxygen Consumption [ Time Frame: 3 months ]Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.
- Quality of Life [ Time Frame: 3 months ]Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.
- New York Heart Association (NYHA) Class [ Time Frame: 3 months ]
The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient's limitations in physical activities caused by cardiac symptoms.
Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.
Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.
Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.
Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.
Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178528
|Centre for Clinical and Basic Research - IRCCS San Raffaele|
|Roma, Italy, 00100|
|IRCCS San Raffaele|
|Roma, Italy, 00100|
|Principal Investigator:||Maurizio Volterrani, MD||IRCCS San Raffaele|
|Study Chair:||Giuseppe MC Rosano, MD, PhD||IRCCS San Raffaele|
|Study Director:||Cristiana Vitale, MD, PhD||IRCCS San Raffaele|