Heart Rate Reduction in Heart Failure

Heart Failure Clinical Trial

— CARVIVA-HF  

Official title:

Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178528
• Other study ID #: CTG001-07
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2010
• Last updated: September 29, 2014
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2014
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• heart failure II-III

• ischemic origin

• stable medications from at least 3 months

• > 3 months from an acute ischemic syndrome or revascularization procedure

• naive on heart rate reducing agents

Exclusion Criteria:

• bradycardia

• hypersensitivity or contraindications to study drugs

• exercise tolerance at 6 minute walking test <100 m or >400 m

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• ivabradine
7.5 mg bd
• "Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
• Carvedilol
25 mg bd

Locations

Country	Name	City	State
Italy	Centre for Clinical and Basic Research - IRCCS San Raffaele	Roma
Italy	IRCCS San Raffaele	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3. — View Citation

Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Tavazzi L. Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial (SHIFT). Eur J Heart Fail. 2010 Jan;12(1):75-81. doi: 10.1093/eurjhf/hfp154. Epub 2009 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Tolerance Assessed by 6 Minute Walking Test	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.	3 months	No
Primary	Maximal Oxygen Consumption	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.	3 months	No
Secondary	Quality of Life	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.	3 months	No
Secondary	New York Heart Association (NYHA) Class	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.	3 months	No

External Links

•   European Society Cardiology guidelines