Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension
|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.
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|