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NCT01712620 · ClinicalTrials.gov registry record · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01712620: Recruiting Phase 2 study of Pulmonary Arterial Hypertension, sponsored by National Institutes of Health Clinical Center (CC).
NCT01712620 is a Phase 2 study of Pulmonary Arterial Hypertension that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 70 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712620, a Phase 2 study of Pulmonary Arterial Hypertension, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to worsening of the disease. A drug called spironolactone has been known to improve blood vessel function and reduce inflammation. Some people with PAH take spironolactone to help treat fluid retention. However, its effect on inflammation and blood vessel function in patients with PAH is not known. Researchers want to see if spironolactone can help these conditions in people with PAH. Objectives: \- To test the effectiveness of spironolactone in treating pulmonary arterial hypertension. Eligibility: \- Individuals at least 18 years of age with pulmonary arterial hypertension. Design: * This study will last for 24 weeks. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will take either spironolactone or a placebo. They will take their study drug or placebo for 7 weeks. Treatment will be monitored with regular blood tests. * In Week 8, participants who have had no reaction to the treatment will receive a higher dose of the drug or placebo. * In Week 12, participants will have a study visit with heart and lung function tests. They will also have a 6-minute walk test, and provide blood and urine samples. * After additional study visits for blood samples, participants will have a final visit in Week 24. The tests from Week 12 will be repeated at this visit.
Primary Outcome
Change in placebo corrected 6-minute walk distance.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Spironolactone
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-01-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT01712620 shows while recruiting
NCT01712620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (85% 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.
NCT01712620 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01712620 about?
NCT01712620 is a clinical study titled "Spironolactone for Pulmonary Arterial Hypertension". Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. In spite of recent advances in treatment, the death rate remains unacceptably high. Lung blood vessel function can be harmed by progressive injuries, such as inflammation, leading to...
What is the current status of trial NCT01712620?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2014-01-10. Estimated completion is 2026-12-31.
What conditions does trial NCT01712620 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT01712620?
The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG).
Who is sponsoring clinical trial NCT01712620?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01712620 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01712620's enrollment target sits among peer trials
70 25th of 63 higher than 39 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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