Heart Rate Reduction in Heart Failure (CARVIVA-HF)

San Donato Group (GSD)

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Carvedilol; Drug: ivabradine; Drug: "Drug:Carvedilol" and "Drug:Ivabradine"

Study type: Interventional

Funder types: Other

Identifiers

NCT01178528

CTG001-07

Details and patient eligibility

About

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.

Full 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

Enrollment: 121 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

121 participants in 3 patient groups

Ivabradine

Experimental group

Description:

7.5 mg bd

Treatment:

Drug: ivabradine

Carvedilol

Active Comparator group

Description:

up to 25 mg bd

Treatment:

Drug: Carvedilol

"Drug:Carvedilol" and "Drug:Ivabradine"

Experimental group

Description:

up to 12.5/5 mg bd

Treatment:

Drug: "Drug:Carvedilol" and "Drug:Ivabradine"