Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00156390 · ClinicalTrials.gov registry record · NA
Predictors of Response to Biventricular Pacing in Heart Failure
A NA study, sponsored by Samir Saba.
- Completed
- Registry status
- NA
- Development phase
- 187
- Enrollment target
NCT00156390 is a NA study that has completed, run by Samir Saba. The registered enrollment target is 187 participants.
The verdict
NCT00156390, a NA study, has completed, sponsored by Samir Saba.
- COMPLETED
- Registry status
- NA
- Development phase
- 187 participants
- Enrollment target
Study Summary
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the deaths will be attributed to worsening pump function while the remainder will be attributable to sudden cardiac death. Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF with dramatic benefits to some patients. Current candidates include those with ventricular conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated that BIV pacing improves myocardial function, functional capacity, quality of life, as well as reduces the incidence of hospitalization and even prolongs life. Despite all this, about one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'. Our group and others have shown that there are direct genetic effects of BiV pacing in an animal model, however, there are gaps in existing knowledge about the effects of left ventricular (LV) pacing site or genetic influences on the degree of response to this novel therapy. This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with the goal of optimizing the degree of benefit and increasing the proportion of patients who respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site will be defi
Interventions
- DEVICE echo-guided left ventricular lead placement
- OTHER LV lead placement as per standard of care (without echo guidance)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2005-06 |
| Est. Completion | 2012-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00156390
The ClinicalTrials.gov registry entry for NCT00156390 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Samir Saba, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which echo-guided left ventricular lead placement is the first listed.
NCT00156390 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00156390 about?
NCT00156390 is a clinical study titled "Predictors of Response to Biventricular Pacing in Heart Failure". Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the...
What is the current status of trial NCT00156390?
This trial is currently completed. It is a NA study. The enrollment target is 187 participants. The study started on 2005-06. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00156390?
The interventions under investigation include: echo-guided left ventricular lead placement (DEVICE), LV lead placement as per standard of care (without echo guidance) (OTHER).
Who is sponsoring clinical trial NCT00156390?
This trial is sponsored by Samir Saba, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.