Recruiting

Spironolactone

Sponsor:

Baylor College of Medicine

Code:

NCT01468571

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spironolactone

Placebo

Study Details

Brief 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.

Conditions

Pulmonary Hypertension

Study ID

NCT01468571

Start date

Jul, 2011

Status verified date

May, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Body weight > 40 kg
  • PAH Diagnostic Group I
  • Stable subjects with no change in PAH specific therapy within the last 4 weeks
  • No change in dose of background therapy (digoxin, diuretic) within the last 2 weeks excluding anticoagulation

Exclusion Criteria:

  • Unable to give informed consent
  • Hemodynamically unstable subjects
  • Pregnant or breast feeding
  • Have significant renal insufficiency (serum creatinine >2.5 mg per deciliter or required hemodialysis)
  • Have significant liver dysfunction (AST or ALT more than three times upper limit of normal)
  • Currently on aldosterone receptor blocker (spironolactone or eplerenone) or ACE inhibitor
  • PH due to left heart disease
  • Unable or unwilling to comply with study procedures

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spironolactone

Drug: Spironolactone Drug: Placebo

experimental: Placebo

Drug: Placebo Drug: Spironolactone

Interventions

Spironolactone

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.

Placebo

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.

Primary outcome measure

  • Change in biomarker levels in the spironolactone treated as compared to placebo treated group. [ Time Frame: 16 week ]

Central Contacts and Locations

Central contacts

Zeenat Safdar, MD

713-798-2400safdar@bcm.edu

Gwendolyn Goodloe

713-798-2400gmb@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Baylor College of Medicine

Last update posted

May 8, 2015

Last verified

May, 2015

Keywords

  • Potassium Sparing Diuretics
  • Right-sided heart failure
  • Edema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2015-05-08.