Status:
COMPLETED
Optimal Cardiac Resynchronization Therapy Pacing Rate
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Cardiac Resynchronization Therapy
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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, cardiopulmon...
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 sequ...
Eligibility Criteria
Inclusion
- Diagnosis with idiopathic dilated cardiomyopathy
- CRT device implanted (with initial indication in accordance with European guidelines) at least 6 months prior to inclusion.
- New York Heart Association functional (NYHA) class II-IV
- Sinus rhythm,
- Hemodynamically stable
- Biventricular pacing \> 90% of the time
- On optimal medical treatment for heart failure with no changes in medications during the past 3 months.
Exclusion
- NYHA I
- unable to perform exercise test (e.g. chronic obstructive pulmonary disease, severe arthritis)
- cancer
- plasma creatinine \> 200 micromole per litre
- an admission for decompensated HF or acute coronary syndrome in the preceding 3 months.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02258061
Start Date
August 1 2011
End Date
June 1 2013
Last Update
October 7 2014
Active Locations (1)
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1
Rigshospitalet, University hospital of Copenhagen
Copenhagen, Denmark, 2100