Phase 2 N=10 Treatment

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

Pulmonary Arterial Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00964678 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Absolute Change in Right Ventricular Ejection Fraction — 10.4 % RVEF — p=0.028

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carvedilol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Absolute Change in Right Ventricular Ejection Fraction	10.4	0.028 sig
SECONDARY Change in Right Ventricular End Systolic Volume	3; 14; 56; 11; 27; 25	0.028 sig
SECONDARY Change in 6 Minute Walk Distance	45; 160; 35; 5; 96	>0.05
SECONDARY Change in Tricuspid Annular Plane Systolic Excursion	0.4; -0.08; -0.12; 0.45; 0.08	>0.05

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.

Eligibility 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 ( 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00964678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.