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NCT01516346 · ClinicalTrials.gov registry record · Phase 2
Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction
A Phase 2 study, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT01516346 is a Phase 2 study that has completed, run by Corporal Michael J. Crescenz VA Medical Center. The registered enrollment target is 44 participants.
The verdict
NCT01516346, a Phase 2 study, has completed, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute walk test) in patients with Heart Failure and Preserved Ejection Fraction (HFPEF). We will also test the hypothesis that the reduction in arterial wave reflections induced by vasoactive therapy will correlate with the improvement in exercise capacity, LV mass, fibrosis and diastolic function. Finally, we will assess whether the hemodynamic response to an acute dose of sublingual nitroglycerin (NTG) can predict the sustained changes in the reflected wave and other hemodynamic parameters in response to chronic vasodilator therapy.
Interventions
- DRUG Placebo
- DRUG Isosorbide Dinitrate
- DRUG Isosorbide Dinitrate + Hydralazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-01 |
| Est. Completion | 2017-08-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01516346
The ClinicalTrials.gov registry entry for NCT01516346 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corporal Michael J. Crescenz VA Medical Center, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01516346 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01516346 about?
NCT01516346 is a clinical study titled "Vasodilator Therapy for Heart Failure and Preserved Ejection Fraction". The main objective is to test the effect of prolonged therapy (24 weeks) with isosorbide dinitrate ± hydralazine on arterial wave reflections (primary endpoint). Secondary endpoints include left ventricular (LV) mass, fibrosis and diastolic function) and exercise capacity (assessed via the 6-minute ...
What is the current status of trial NCT01516346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2012-01. Estimated completion is 2017-08-18.
What interventions are being tested in trial NCT01516346?
The interventions under investigation include: Placebo (DRUG), Isosorbide Dinitrate (DRUG), Isosorbide Dinitrate + Hydralazine (DRUG).
Who is sponsoring clinical trial NCT01516346?
This trial is sponsored by Corporal Michael J. Crescenz VA Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.
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