Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension

Sponsored by Virginia Commonwealth University

Phase Quota
Phase 1

The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.

Study Start Date: June 2010

Estimated Completion Date: May 2014

Specialties: Cardiology: Clinical Pharmacology,Hypertension Internal Medicine: Cardiology,Clinical Pharmacology Pulmonology: CV/Thromboembolic Pharmacy: Cardiac/Hypertension


  • Drug: Carvedilol

Inclusion criteria

  • Idiopathic, familial or associated PAH, WHO group 1
  • NYHA class III or IV
  • Clinically stable with optimized treatment for at least 3 months
  • No or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment
  • Age > 18 years
  • Mean pulmonary artery pressure (mPAP) > 40 mmHg
  • Right atrial pressure (RAP) > 10 mmHg
  • 6 minute walk distance (6MWD) 100-400 m

Exclusion criteria

  • Structural heart disease unrelated to PAH
  • Recent (<3 months) treatment with an intravenous positive inotropic agent
  • Current use of ß-blockers
  • History of reactive airways disease
  • History of adverse reaction to ß-blockers
  • Heart block on ECG or resting heart rate < 60 bpm
  • Cardiac index < 1.8 l/min/m2
  • Systemic hypotension (systolic pressure < 90 mmHg)
  • Pulmonary capillary wedge pressure > 15 mmHg
  • Inability to give informed consent
  • Contraindications to CT and/or PET scanning
  • Coagulopathy (INR>1.5 or platelet count<50000/mm3)
  • Severe renal insufficiency (creatinine clearance <30 ml/min/m2)
  • Malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study

Study Locations And Contact Information

  • Virginia Commonwealth University, Richmond Virginia
    Contact: Daniel C Grinnan, MD 804-519-8705

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