NCT03405831

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

January 5, 2018

Last Update Submit

March 4, 2019

Conditions

Cardiac Allograft VasculopathyTransplanted Heart Complication

Keywords

Heart transplantationExercise capacityHeart rateCardiac allograft vasculopathy

Outcome Measures

Primary Outcomes (1)

  • ΔVO2max

    The change in VO2max (ΔVO2max) (mL/kg/min) from baseline to 12 weeks follow-up. The peak oxygen uptake (VO2max) reflects the maximal ability of a person to take in, transport and use oxygen, and it defines the functional aerobic capacity. It is used to provide an overall assessment of exercise capacity.

    The VO2max is assessed at baseline and 12 weeks follow-up.

Secondary Outcomes (16)

  • ΔHRrest

    12 weeks

  • ΔHRreserve

    12 weeks

  • ΔLVmass

    12 weeks

  • ΔLVEF

    12 weeks

  • Δmitral deceleration time

    12 weeks

  • +11 more secondary outcomes

Other Outcomes (1)

  • Coronary vessel characterization

    Substudy objective is only evaluated at baseline

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

Study participants in this arm will receive ivabradin 5 mg bid for a period of 12 weeks.

Drug: Ivabradine

Placebo

PLACEBO COMPARATOR

Study participants in this arm will receive placebo bid for a period of 12 weeks.

Drug: Placebo

Interventions

IvabradineDRUG

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

Also known as: Procoralan
Ivabradine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK-2100, Denmark

RECRUITING

MeSH Terms

Interventions

Ivabradine

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lærke Nelson, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn Gustafsson, MD PhD DMSc

CONTACT

+45 35459743finng@dadlnet.dk

Lærke Nelson, MD

CONTACT

+45 35459549laerke.marie.nelson@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective single-center, double-blinded, placebo controlled, randomized study in long-term heart transplant recipients. Patients who meet the eligibility criteria will be randomized 1:1 at inclusion for one of two treatment groups: (i) treatment with ivabradine 5 mg bid or (ii) treatment with placebo bid for a period of 12 weeks. 35 participants will be enrolled.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, DMSci; Professor of Cardiology; Team Leader Advanced Heart Failure, Transplantation and Mechanical Circulatory Support; Department of Cardiology; The Heart Center; Copenhagen University Hospital; Rigshospitalet

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 23, 2018

Study Start

April 17, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)