Effect of Ivabradine on Exercise Capacity After Heart Transplantation

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates whether treatment with ivabradine compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest.

Patients will receive treatment with either ivabradin or placebo for a period of 12 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finn Gustafsson
• Collaborators: Danish Heart Foundation; Rigshospitalet, Denmark

Criteria

Inclusion Criteria:

• Patients > 1 year post heart transplantation

• CAV verified by coronary angiography or intravascular ultrasound

• Resting HR > 80 bpm

• Age > 18 years

• Signed informed consent

Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will be required to provide a negative urine human chorionic gonadotropin (hCG) before entering the study and must use a safe birth control method in the total study period.

Exclusion Criteria:

• Rejection (>H1R) < 3 months

• Severe renal failure (estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2)

• Inability or contraindication to perform a VO2 max test

• Presence of any condition that might per se influence exercise performance

• Known contraindication for treatment with ivabradine

• Hypersensitivity to the active substance or to any of the excipients of either study drug