Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

• Sponsor: The Leeds Teaching Hospitals NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02086422
• Collaborator: (none)
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Drug: ivabradine; Drug: Placebo; Other: Exercise	N/A

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ivabradine Exercise with ivabradine	Drug: ivabradine; Other: Exercise
Placebo Comparator: Placebo Exercise with placebo	Drug: Placebo; Other: Exercise

Outcome Measures

Primary Outcome Measures

1. Examining the effects of iatrogenic CI on exercise capacity [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS2 9JT

Sponsors and Collaborators

• The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02086422
• Other Study ID Numbers: CD13/10799
• First Posted: Mar 13, 2014
• Last Update Posted: Feb 26, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Feb 26, 2016