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A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension

General Information

Age Group

Adult

Status

Active

Protocol Number

12-CC-0211

Offered At

National Institutes of Health
Bethesda, MD

Principal Investigator

Steven Nathan, MD

Eligibility Information

  • WHO Group 1 PH patients on either no medical therapy or stable medical therapy for at least the past 4 weeks (defined as no new PAH-specific therapy, no change in the dose of current PAH-specific therapy and no change in NYHA/WHO functional classification within the past 4 weeks) are eligible. The following parameters on RHC are required to meet the hemodynamic definition of PAH:
    • Mean pulmonary artery pressure of > 25 mmHg at rest
    • Pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left ventricular end-diastolic pressure of less than or equal to 12 mmHg)
    • Pulmonary vascular resistance of > 3 Wood units (240 dyn.s.cm(-5)
  • If clinically indicated at the time of enrollment, then a RHC will be performed at the NIH Clinical Center upon study entry under a procedural consent
  • Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and for the duration of study participation

Ineligibility Information

  • Patients with WHO Group 1 PH and evidence of right heart failure as defined by:
    • NYHA/WHO class IV symptoms
    • Echocardiographic evidence of severe RV dysfunction
    • Clinical evidence of right heart failure which may include, but is not limited to elevated jugular venous pressure, ascites, lower extremity edema
  • Patients with WHO Group 1 pulmonary hypertension and a prior diagnosis of cirrhosis with portal hypertension as evidenced by a history of ascites, hepatic encephalopathy and/or varices prior to enrollment
  • Patients with WHO Group 1 pulmonary hypertension and evidence of active infection, (HIV patients with two consecutive viral loads of < 500 on their most recent determinations within the past 12 months will be considered to have inactive infection)
  • Patients with WHO Group 1 pulmonary hypertension who have taken spironolactone or eplerenone within the last 30 days
  • Known or suspected allergy to spironolactone
  • Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)
  • Age < 18 years
  • Chronic kidney disease
  • Serum potassium at the time of enrollment of > 5 mEq/L
  • Concurrent use of an ACE inhibitor and angiotensin II receptor blocker OR Patients currently taking the maximum recommended dose of an ACE inhibitor or an angiotensin II receptor blocker
  • Women currently taking drospirenone-containing oral contraceptives