The Effect of Ivabradine Treatment on Exercise Capacity in Patients with Chronic Rejection after Heart Transplantation

The Effect of Ivabradine Treatment on Exercise Capacity in Patients with Cardiac Allograft Vasculopathy after Heart Transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004706-33-DK

Enrollment

Registered

2017-02-01

Start date

2017-03-31

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac allograft vasculopathy and elevated resting heart rate in heart transplant recipients MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849

Interventions

Trade Name: Procoralan Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVABRADINE CAS Number: 155974-00-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients > 1 year post heart transplantation • CAV verified by coronary angiography or IVUS • Resting HR > 80 bpm • Age > 18 years • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Rejection (>H1R) < 3 months • Severe renal failure (estimated GFR < 30 mL/min/1.73 m2) • Inability or contraindication to perform a VO2max 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether treatment with ivabradine (5 mg bid for 12 weeks) compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest. Primary endpoint: To compare the efficacy between treatment groups by assessing the difference in exercise capacity by •Change in VO2 max (?VO2max) - Change in ;Secondary Objective: To evaluate whether treatment with ivabradine (5 mg bid for 12 weeks) compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest. Seondary endpoints: To compare the efficacy between treatment groups by assessing the difference in •Change in resting HR (?HRrest) •Change in HR reserve (?HRreserve) •Change in LV mass by MRI (?LVmass) •Change in LVEF by MRI (?LVEF) •Change in LV diastolic function (? TTE and MRI diastolic parameters) •Quality of life (QOL) ;Primary end point(s): •Change in VO2max (?VO2max);Timepoint(s) of evaluation of this end point: 12 weeks from initiation of study medication	—

Measure

Time frame

Main Objective: To evaluate whether treatment with ivabradine (5 mg bid for 12 weeks) compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest. Primary endpoint: To compare the efficacy between treatment groups by assessing the difference in exercise capacity by •Change in VO2 max (?VO2max) - Change in ;Secondary Objective: To evaluate whether treatment with ivabradine (5 mg bid for 12 weeks) compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest. Seondary endpoints: To compare the efficacy between treatment groups by assessing the difference in •Change in resting HR (?HRrest) •Change in HR reserve (?HRreserve) •Change in LV mass by MRI (?LVmass) •Change in LVEF by MRI (?LVEF) •Change in LV diastolic function (? TTE and MRI diastolic parameters) •Quality of life (QOL) ;Primary end point(s): •Change in VO2max (?VO2max);Timepoint(s) of evaluation of this end point: 12 weeks from initiation of study medication

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Secondary

Measure	Time frame
Secondary end point(s): • Change in resting HR (?HRrest) • Change in HR reserve (?HRreserve) • Change in LV mass by MRI (?LVmass) • Change in LVEF by MRI (?LVEF) • Change in LV diastolic function (? TTE and MRI diastolic parameters. TTE: mitral deceleration time, E/é, E/A ratio, isovolumetric relaxation time. MRI: transmitral flow rate, pulmonary venous flow, LVEDV, LVESV, LV peak filling rate, time to peak filling) • QOL ;Timepoint(s) of evaluation of this end point: 12 weeks from initiation of study medication	—

Measure

Time frame

Secondary end point(s): • Change in resting HR (?HRrest) • Change in HR reserve (?HRreserve) • Change in LV mass by MRI (?LVmass) • Change in LVEF by MRI (?LVEF) • Change in LV diastolic function (? TTE and MRI diastolic parameters. TTE: mitral deceleration time, E/é, E/A ratio, isovolumetric relaxation time. MRI: transmitral flow rate, pulmonary venous flow, LVEDV, LVESV, LV peak filling rate, time to peak filling) • QOL ;Timepoint(s) of evaluation of this end point: 12 weeks from initiation of study medication

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Countries

Denmark

Contacts

Public ContactFinn Gustafsson

Finn Gustafsson

finng@dadlnet.dk+4535459743

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 17, 2026