Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT01468571|
Recruitment Status : Unknown
Verified May 2015 by Zeenat Safdar, Baylor College of Medicine.
Recruitment status was: Recruiting
First Posted : November 9, 2011
Last Update Posted : May 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Spironolactone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Spironolactone on Collagen Metabolism in Pulmonary Arterial Hypertension|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
Drug: Spironolactone Drug: Placebo
50 mg po daily of spironolactone for 8 weeks. A cross-over study where each subject will receive spironolactone or placebo in a random order for 8 weeks each.
Other Name: Aldactone
Drug: Placebo Drug: Spironolactone
Each subject will receive placebo or spironolactone for 8 weeks. At the end of week 8, treatment arm for each subject will be blindly switched.
So if a study patient received placebo for the first 8 weeks then he/she will be switched to receive active drug (spironolactone) for the next 8 weeks.
Other Name: sugar pill
- Change in biomarker levels in the spironolactone treated as compared to placebo treated group. [ Time Frame: 16 week ]50 participants will be enrolled in a 16-week study, and each subject will receive placebo or active drug in a random order. At the end of week 8, treatment arm for each subject will be blindly switched. Biomarker levels will be drawn 3 times (baseline, week 8, and week 16) during the study period for each subject.
- Number of adverse events in patients treated with spironolactone as compared to placebo. [ Time Frame: 16 week ]Safety and tolerability of spironolactone as compared to placebo in PAH.
- Change in six-minute walk distance from baseline to week 8 and week 16. [ Time Frame: 16 week ]
- Composite end-point [ Time Frame: 16 week ]Composite end-point predefined as greater than 10% increase in walk distance, improvement by at least one functional class and absence of clinical worsening. Clinical worsening will be defined as hospitalization for worsening PAH, all-cause death, addition of prostacyclin therapy, lung transplantation, or atrial septostomy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468571
|Contact: Zeenat Safdar, MDfirstname.lastname@example.org|
|Contact: Gwendolyn Goodloeemail@example.com|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Zeenat Safdar, MD||Baylor College of Medicine|