Status:
COMPLETED
The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients.
Lead Sponsor:
University of Leeds
Conditions:
Chronic Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.
Detailed Description
Original proposal: Does iatrogenic chronotropic incompetence lead to impaired exercise capacity in patients with CHF Aim The aim of this proposal is to examine the effects of iatrogenic CI on exercis...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- We will only include patients able to give informed written consent, which will be obtained in all subjects, and those capable of performing a peak exercise test. Since we are performing the study on three groups of patients, further inclusion criteria for each group are outlined below.
- Inclusion criteria - CRT-sinus rhythm group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. These individuals will be on optimal medical therapy for their heart failure with no change in medication or exacerbation for the preceding 3 months. They will not currently be taking ivabradine.
- Inclusion criteria - CRT-atrial fibrillation group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. All patients will be previously pacemaker dependant or have 'blocked' atrial fibrillation either due to medical therapy or previous atrio-ventricular nodal ablation.
- Inclusion criteria - control group The control subjects (n=25) will be recruited from the general pacemaker clinic. They will undergo echocardiography to exclude structural heart disease. They will have no contraindications to exercise testing or ivabradine.
- Exclusion Criteria:
- We will exclude subjects with musculoskeletal disorders limiting exercise capacity, patients with peripheral vascular disease, those with inflammatory disorders such as rheumatoid arthritis, and airways disease. Other exclusions include contraindications to ivabradine use such as severe hepatic impairment, significant renal impairment (creatinine clearance \<15ml.min-1), and long QT syndrome. We will only include patients able to give informed written consent, which will be obtained in all subjects.
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Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02247245
Start Date
September 1 2014
End Date
September 1 2015
Last Update
January 2 2020
Active Locations (1)
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1
Leeds Institute of Cardiovascular and Metabolic Medicine
Leeds, West Yorkshire, United Kingdom, LS13ex