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If Channel Blockade With Ivabradine in Patients With Diastolic Heart Failure

NCT00757055 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-11-25

No results posted yet for this study

Summary

The purpose of this study is to investigate whether the medicine ivabradine, a novel drug which slows the heart rate has a favourable effect on patients with diastolic heart failure.

Ivabradine is a specific heart rate-lowering agent. It has a licence for treating patients with angina who are intolerant of agents such as beta blockers or whose angina is not adequately controlled. It has been shown to prolong exercise tolerance in these patients and to reduce the frequency of chest pain. Its mechanism of action is felt to be purely due to reducing heart rate, by as much as 10 beats per minute at rest, as well as by reducing the heart rate response to exercise.

Patients with diastolic heart failure often complain of breathlessness on exertion which relates to the stiffness or lack of compliance of their heart i.e. the heart fails to relax rapidly enough to allow it to fill with blood between each heart beat. This may result in high pressure in the heart chamber which backs up in to the lungs and may be experienced as breathlessness. There is little evidence that any specific therapy benefits patients with this type of heart failure besides treating coexisting problems such as high blood pressure or angina. By slowing the heart rate down with ivabradine, the heart would have a longer time to fill during exercise which would make it more effective. This slowing of the heart rate may therefore relieve the breathlessness experienced on activity such as walking to the shops or up a flight of stairs etc.

Conditions

  • Diastolic Heart Failure

Interventions

DRUG

Ivabradine

Ivabradine titrated to heart rate starting at 5 mg bd and increasing to maximum of 7.5 mg bd or reducing to 2.5 mg if heart rate \< 60 bpm.

DRUG

Placebo

No active treatment given

Sponsors & Collaborators

  • St Vincent's University Hospital, Ireland

    lead OTHER

Principal Investigators

  • Dermot J McCaffrey, MB MRCPI FRACP · St Vincents University Hospital, Elm Park Dublin 4 Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • Ireland

Study Locations

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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 NCT00757055 on ClinicalTrials.gov