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NCT03648385 · ClinicalTrials.gov registry record · Phase 2
Effects of DHEA in Pulmonary Hypertension
A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03648385: Completed Phase 2 study of Pulmonary Arterial Hypertension, sponsored by Rhode Island Hospital.
NCT03648385 is a Phase 2 study of Pulmonary Arterial Hypertension that has completed, run by Rhode Island Hospital. The registered enrollment target is 26 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03648385, a Phase 2 study of Pulmonary Arterial Hypertension, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this crossover trial is to determine whether the study drug dehydroepiandrosterone (DHEA) improves right ventricular longitudinal strain measured by cardiac magnetic resonance imaging at 18 weeks AND 40 weeks compared to placebo and to assess side effects and safety in pulmonary arterial hypertension.
Primary Outcome
Longitudinal strain is determined using standard cine imaging and Tissue Tracking (Strain) software (Tissue Tracking plugin, Circle Cardiovascular Imaging). Study MRIs were performed at a core MRI facility on a single Siemens 1.5T Aera with full Advanced Cardiac Package and XQ Gradients (45 mT/m @ 200 T/m/s) used for research grade imaging. 2D RV longitudinal strain: Measured from RV free wall of 4-chamber view cine CMR image. RV wall is divided into 6 equal segments. Strain can be either positi
Conditions Studied
Interventions
- OTHER Placebo
- DRUG DHEA tablet
Study Locations (1)
Rhode Island
- Rhode Island Hospital Pulmonary Hypertension Center - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 2 |
What the finished NCT03648385 record still lists
NCT03648385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03648385 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT03648385 about?
NCT03648385 is a clinical study titled "Effects of DHEA in Pulmonary Hypertension". The goal of this crossover trial is to determine whether the study drug dehydroepiandrosterone (DHEA) improves right ventricular longitudinal strain measured by cardiac magnetic resonance imaging at 18 weeks AND 40 weeks compared to placebo and to assess side effects and safety in pulmonary arterial...
What is the current status of trial NCT03648385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-01-09. Estimated completion is 2024-12-30.
What conditions does trial NCT03648385 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT03648385?
The interventions under investigation include: Placebo (OTHER), DHEA tablet (DRUG).
Who is sponsoring clinical trial NCT03648385?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03648385 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Arterial Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03648385's enrollment target sits among peer trials
26 46th of 63 higher than 18 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension 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.
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