Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

Chronic Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02086422
• Other study ID #: CD13/10799
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2013
• Last updated: February 25, 2016
• Start date: July 2013

Study information

• Verified date: February 2016
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Klaus Witte, FRCP, MD
• Phone: 01133926642
• Email: k.k.witte[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• ivabradine

• Placebo

Other:
• Exercise

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No