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Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ivabradine
Placebo
Exercise
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ivabradine

Placebo

Arm Description

Exercise with ivabradine

Exercise with placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 26, 2013
Last Updated
February 25, 2016
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02086422
Brief Title
Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
ivabradine
Arm Type
Active Comparator
Arm Description
Exercise with ivabradine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Exercise with placebo
Intervention Type
Drug
Intervention Name(s)
ivabradine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Examining the effects of iatrogenic CI on exercise capacity
Description
Each subject will undergo a full echocardiographic examination.We will assess LV systolic and diastolic function variables, mitral regurgitation, and pulmonary artery pressure.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus Witte, FRCP, MD
Phone
01133926642
Email
k.k.witte@leeds.ac.uk
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS2 9JT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Witte, FRCP, MD
Phone
01133926642
Email
k.k.witte@leeds.ac.uk

12. IPD Sharing Statement

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Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

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