The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. (TREPPE)
Chronic Heart Failure, Atrial Fibrillation, Arrhythmia, Sinus
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring CHF, AF, SR, HFREF, CRT
Eligibility Criteria
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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Sites / Locations
- Leeds Institute of Cardiovascular and Metabolic Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Experimental
Placebo
Ivabradine
Atrial fibrillation
Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.
Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.
Subjects are (double blind) randomised to either a low base pacing rate (30) or a standard base rate (60), with rate adaptive algortithms switched on.