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The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. (TREPPE)

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ClinicalTrials.gov Identifier: NCT02247245
Recruitment Status : Unknown
Verified September 2014 by Haqeel Jamil, University of Leeds.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Haqeel Jamil, University of Leeds

Brief Summary:
To examine the effects of heart rate reduction on exercise capacity in control subjects and patients with chronic heart failure.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Atrial Fibrillation Arrhythmia, Sinus Drug: Ivabradine Other: Atrial fibrillation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Iatrogenic Chronotropic Incompetence on Exercise Tolerance in Pacemaker Patients With Chronic Heart Failure.
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects are given a placebo capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.
Active Comparator: Ivabradine
Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.
Drug: Ivabradine
Ivabradine 7.5mg
Other Name: Precorolan

Experimental: Atrial fibrillation
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.
Other: Atrial fibrillation
Pacemaker base rate alteration




Primary Outcome Measures :
  1. Change in exercise capacity [ Time Frame: 2 weeks ]
    Comparing cardiopulmonary exercise testing performance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247245


Contacts
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Contact: Haqeel A Jamil, MbChB MRCP 01133923131 ext 23131 haqeel@doctors.net.uk
Contact: Klaus K Witte, FRCP MD 01133923131 ext 23131 k.k.witte@leeds.ac.uk

Locations
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United Kingdom
Leeds Institute of Cardiovascular and Metabolic Medicine Recruiting
Leeds, West Yorkshire, United Kingdom, LS13ex
Contact: Haqeel Jamil, MbChB    01133923131 ext 23131    haqeel.jamil@leedsth.nhs.uk   
Contact: Klaus Witte, MBBS    01133923131 ext 23131    k.k.witte@leeds.ac.uk   
Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Klaus K Witte, FRCP MD University of Leeds
Principal Investigator: Haqeel A Jamil, MbChB MRCP University of Leeds

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haqeel Jamil, Cardiology Registrar and Clinical Research Fellow, University of Leeds
ClinicalTrials.gov Identifier: NCT02247245     History of Changes
Other Study ID Numbers: LIGHT-TREPPE-1
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Haqeel Jamil, University of Leeds:
CHF
AF
SR
HFREF
CRT
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Arrhythmia, Sinus
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes