Phase 2
Completed N=10
Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT00964678 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Absolute Change in Right Ventricular Ejection Fraction — 10.4 % RVEF — p=0.028
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.
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 |
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.
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. Informational only — not medical advice.