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Aldosterone Receptor Antagonist

Spironolactone for Pulmonary Hypertension

Phase 4
Waitlist Available
Led By Zeenat Safdar, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 week
Awards & highlights

Study Summary

The purpose of this study is to determine the effects of spironolactone on collagen markers in a large number of patients with pulmonary hypertension. In addition, safety and tolerability of spironolactone, an aldosterone receptor antagonist, in patients with pulmonary arterial hypertension, will be determined.

Eligible Conditions
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in biomarker levels in the spironolactone treated as compared to placebo treated group.
Secondary outcome measures
Change in six-minute walk distance from baseline to week 8 and week 16.
Composite end-point
Number of adverse events in patients treated with spironolactone as compared to placebo.

Trial Design

2Treatment groups
Experimental Treatment
Group I: SpironolactoneExperimental Treatment1 Intervention
Drug: Spironolactone Drug: Placebo
Group II: PlaceboExperimental Treatment1 Intervention
Drug: Placebo Drug: Spironolactone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,362 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,814,055 Total Patients Enrolled
Zeenat Safdar, MDPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension
Zeenat Safdar 2011. "Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01468571.
All > Pulmonary Arterial Hypertension > High Blood Pressure
~4 spots leftby May 2025
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