The Influence of Heart Rate Limitation on Exercise Tolerance in Pacemaker Patients. (TREPPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure Atrial Fibrillation Arrhythmia, Sinus||Drug: Ivabradine Other: Atrial fibrillation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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
- Change in exercise capacity [ Time Frame: 2 weeks ]Comparing cardiopulmonary exercise testing performance
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
|Contact: Haqeel A Jamil, MbChB MRCP||01133923131 ext email@example.com|
|Contact: Klaus K Witte, FRCP MD||01133923131 ext firstname.lastname@example.org|
|Leeds Institute of Cardiovascular and Metabolic Medicine||Recruiting|
|Leeds, West Yorkshire, United Kingdom, LS13ex|
|Contact: Haqeel Jamil, MbChB 01133923131 ext 23131 email@example.com|
|Contact: Klaus Witte, MBBS 01133923131 ext 23131 firstname.lastname@example.org|
|Principal Investigator:||Klaus K Witte, FRCP MD||University of Leeds|
|Principal Investigator:||Haqeel A Jamil, MbChB MRCP||University of Leeds|