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NCT00521534 · ClinicalTrials.gov registry record
Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure
A clinical trial, sponsored by VA Pittsburgh Healthcare System.
- Completed
- Registry status
- 19
- Enrollment target
NCT00521534: Completed study, sponsored by VA Pittsburgh Healthcare System.
NCT00521534 is a clinical trial that has completed, run by VA Pittsburgh Healthcare System. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521534 has completed, sponsored by VA Pittsburgh Healthcare System.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study Summary
Background and Introduction: SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart failure. The disorder is prevalent among males, estimated to affect upto 24% of the general population. Its prevalence increases with age, and it is particularly prevalent among patients with congestive heart failure with the prevalence rising to 51% in that group. Interestingly, recent evidence points to a potential impact for treating sleep disordered breathing, on heart failure patients. At the same time, recent reports of a beneficial impact of atrial overdrive pacing on SDB, have stirred interest in a potentially effective and well tolerated non-pharmacologic means of therapy for this disorder. Particularly at a time when cardiac resynchronization therapy utilizing biventricular pacing has demonstrated significant impact on heart failure, the interplay between CHF and SDB pacemaker based therapy begs further exploration. The interdependence of potential positive impact on each entity needs to be elucidated for further research and refinement of therapeutic tools. Furthermore, this study aims to explore potential neurohormonal influence on and affection by each of these disorders. Specific Aims and Hypotheses: Specific Aim #1: To assess the effect of cardiac resynchronization therapy (CRT) with or without atrial pacing on SDB in patients with advanced CHF at 8 and 16 weeks after implementation of therapy. Hypothesis #1: Resynchronization therapy improves SDB, the effect may anticipate or lag improvement in heart failure. Atrial pacing has a beneficial effect in addition to CRT. Specific Aim #2: To explore the effect of CRT on cardiac neuro-hormonal activity in relation to its effects on CHF and SDB. Hypothesis #2: CRT neuro-hormonal modulation is a common path in
Interventions
- DEVICE CRT with atrial overdrive pacing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-11 |
What the finished NCT00521534 record still lists
NCT00521534 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CRT with atrial overdrive pacing is the first listed.
NCT00521534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00521534 about?
NCT00521534 is a clinical study titled "Impact of Resynchronization Therapy on Sleep Disordered Breathing in Advanced Congestive Heart Failure". Background and Introduction: SDB is increasingly recognized as a co-morbidity with significant impact on overall health. The disorder has been implicated in the development of hypertension, atherosclerotic cardiovascular disease as well as arrhythmia, stroke and the progression of congestive heart ...
What is the current status of trial NCT00521534?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2006-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00521534?
The interventions under investigation include: CRT with atrial overdrive pacing (DEVICE).
Who is sponsoring clinical trial NCT00521534?
This trial is sponsored by VA Pittsburgh Healthcare System, which has 17 total clinical trials registered on ClinicalTrials.gov.
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