Trials / Completed
CompletedNCT02258061
Optimal Cardiac Resynchronization Therapy Pacing Rate
Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-ischemic Heart Failure Patients: a Randomized Crossover Pilot Trial.
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known. Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).
Detailed description
This is a double-blinded randomized crossover pilot study testing two basal pacing rates: DDD-60 versus DDD-80. Each patient is paced for 2 periods of 90 days with DDD-60 and DDD-80 in a randomly sequence. Blood samples NT-proBNP plasma levels are analysed at baseline and at the end of each phase using electrochemiluminescence-immunoassay. Patients rest for 15 minutes before the samples are taken. These result are monitored by supervisory group to ensure that increase of more than 15% than baseline values result in termination of study. Investigators conduct two distinct questionnaires (Minnesota Living with Heart Failure (LIfHE) questionnaire and Medical Outcome Survey Short Form (SF-36)) A symptom limiting bicycle (Ergoline, Baden-Württemberg, Germany) exercise test is performed to measure maximum work capacity and oxygen consumption at each phase. Recordings of resting muscle sympathetic nerve activity (MSNA) are sought in all patients at both rates of pacing. All patients are studied on the same set-up in the semi-recumbent position after 30 minutes of rest. Tungsten microelectrodes (Iowa Bioengineering) are inserted into the common peroneal nerve just below the knee.
Conditions
- Cardiac Resynchronization Therapy
- Heart Failure
- Bi-ventricular Pacing
- Sympathetic Activity
- Quality of Life
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | DDD-80 | Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study. |
| PROCEDURE | DDD-60 | Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study. |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2014-10-07
- Last updated
- 2014-10-07
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02258061. Inclusion in this directory is not an endorsement.