NCT02086422

Brief Summary

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.

Trial Health

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Trial Health Score

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

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

Study Start

First participant enrolled

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

November 26, 2013

Last Update Submit

February 25, 2016

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Examining the effects of iatrogenic CI on exercise capacity

    Each subject will undergo a full echocardiographic examination.We will assess LV systolic and diastolic function variables, mitral regurgitation, and pulmonary artery pressure.

    24 months

Study Arms (2)

ivabradine

ACTIVE COMPARATOR

Exercise with ivabradine

Drug: ivabradineOther: Exercise

Placebo

PLACEBO COMPARATOR

Exercise with placebo

Drug: PlaceboOther: Exercise

Interventions

ivabradineDRUG
ivabradine
PlaceboDRUG
Placebo
ExerciseOTHER
Placeboivabradine

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • Cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS2 9JT, United Kingdom

RECRUITING

MeSH Terms

Interventions

IvabradineExercise

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Klaus Witte, FRCP, MD

CONTACT

01133926642k.k.witte@leeds.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

March 13, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

GB(1)