Atrial Fibrillation Clinical Trial
— TREPPEOfficial title:
The Influence of Iatrogenic Chronotropic Incompetence on Exercise Tolerance in Pacemaker Patients With Chronic Heart Failure.
Verified date | December 2019 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Institute of Cardiovascular and Metabolic Medicine | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Leeds |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Oxygen Consumption (Peak VO2) | Cardiopulmonary exercise testing performance - measuring peak oxygen uptake during a treadmill CPEX test. Subjects were exercised using the Bruce protocol, modified by the addition of a "stage 0" at onset consisting of 3 min of exercise at 1.61 km·h-1 (1 mile·h-1) with a 5% gradient. Expired air was collected and metabolic gas exchange analysis performed in order to measure the maximal oxygen consumption (peak VO2) (Sensormedics, Yorba Linda, California). The CPX equipment was recalibrated before every exercise test. All test subjects were encouraged to exercise to exhaustion before starting the test, and no further motivation or instructions were given. |
Each test lasts up to 20 minutes |
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