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

Completed · Phase 1/Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID: NCT00964678
Run by: Virginia Commonwealth University
People needed: 10
Starts: 2010-06-01
Expected to finish: 2014-05-01
Last updated by the study team: 2017-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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