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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborators: GlaxoSmithKline; National Center for Research Resources (NCRR)
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• idiopathic, familial or associated PAH, WHO group 1

• NYHA class II or III

• clinically stable with optimized PAH 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) > 25 mmHg

• 6 minute walk distance (6MWD) over 100m

Exclusion Criteria:

• Structural heart disease unrelated to PAH

• Recent (<3 months) treatment with an intravenous positive inotropic agent

• current use of β-blockers

• history of reactive airways disease

• history of adverse reaction to β-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.