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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: Completed Phase 2 study, sponsored by Corporal Michael J. Crescenz VA Medical Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The dimensionless ratio of backward (reflected) to forward wave amplitude. Higher values imply more wave reflection.
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 |
What the finished NCT01516346 record still lists
NCT01516346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01516346 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01516346's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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