Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

NCT ID: NCT02086422

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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Patients with CHF benefit from heart rate lowering, and the investigators have previously demonstrated that this does not adversely affect exercise tolerance. In a pacemaker population we also have shown that preventing heart rate lowering is detrimental in terms of symptoms and prognosis.

The aim of the study is to therefore to establish whether heart rate limitation in patients with heart failure has a negative impact on exercise capacity. If the investigators establish that this is not the case, physicians will be able to confidently prescribe heart rate lowering agents, and programme pacemakers to allow bradycardia without the concern that there will be detrimental effects of symptom.

Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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ivabradine

Exercise with ivabradine

Group Type ACTIVE_COMPARATOR

ivabradine

Intervention Type DRUG

Exercise

Intervention Type OTHER

Placebo

Exercise with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Exercise

Intervention Type OTHER

Interventions

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ivabradine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Able to walk on a treadmill Able to provide consent Heart failure (or not) depending upon the arm. Patients with atrial fibrillation to have had an AV node ablation (or very slow response to AF)

Exclusion Criteria

* Cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Klaus Witte, FRCP, MD

Role: CONTACT

01133926642

Facility Contacts

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Klaus Witte, FRCP, MD

Role: primary

01133926642

Other Identifiers

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CD13/10799

Identifier Type: -

Identifier Source: org_study_id

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