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Effect of Ivabradine on Exercise Capacity After Heart Transplantation

NCT03405831 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-05

No results posted yet for this study

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.

Conditions

  • Cardiac Allograft Vasculopathy
  • Transplanted Heart Complication

Interventions

DRUG

Ivabradine

Ivabradine, oral tablets, 5 mg, coated in gelatine capsules to ensure blinding, 1 capsule twice a day, for a period of 12 weeks

DRUG

Placebo

Placebo, gelatine capsules to ensure blinding, 1 capsule twice daily, for a period of 12 weeks

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Finn Gustafsson

    lead OTHER

Principal Investigators

  • Lærke Nelson, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03405831 on ClinicalTrials.gov