N/A
N=30
PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01586156 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Nov 2017
Primary outcome: Primary: Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography) — 1.0; 0.6; 0.9; 0.8 standardized uptake value (SUV) — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carvedilol (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography) |
1.0; 0.6; 0.9; 0.8; 0.6; 0.7 | 0.04 sig |
| SECONDARY Urinary cAMP (Cyclic Adenosine Monophosphate)/Creatinine |
1.4; 0.6; 1.0; 1.3; 0.8; 0.7 | 0.04 sig |
| SECONDARY Beta-Adrenergic Receptor (Alprenolol Binding Assay) |
92254; 85230; 82779; 79083; 84554; 83730 | 0.02 sig |
Summary
Pulmonary arterial hypertension (PAH) is a progressive disease of the pulmonary vasculature leading to elevated pulmonary pressure and right ventricular (RV) dysfunction with heart failure. Measures of RV function are better predictors of mortality and long term outcomes than pulmonary vascular resistance. The interaction between RV function and the pulmonary circulation is not fully understood, but increased after load appears insufficient to explain right heart failure. Yet, all approved PAH therapies target vasodilation of the pulmonary vasculature to lower pressures
Eligibility Criteria
Inclusion Criteria
- Men and women age 18 or older not greater than age 65 years
- Diagnosis of pulmonary arterial hypertension class 1, 3, 4, 5 (Dana Point 2008)
- NYHA (New York Health Association)/WHO (World Health Organization) Class I-III
- PAH medications must have been initiated according to the latest consensus statement recommendations and remained stable for the last 30 days
- Women of child-bearing age must use a double-barrier local contraception till completion of the study
- Subjects must demonstrate understanding of the study, sign the informed consent, and have a reliable method of communication for contact and ability to comply with the study requirements
Exclusion Criteria
- Participation in any other treatment studies during enrollment
- Significant illness in the past 30 days requiring hospitalization
- Hepatic insufficiency (transaminase levels > 4 fold the upper limit of normal or bilirubin > 2 fold the upper limit of normal),
- History of HIV, Hepatitis B or C
- Serum creatinine > 2.8 mg/dl
- Pregnancy, breast-feeding, or lack of safe contraception
- Acute decompensated heart failure within past 30 days
- Known allergy or intolerance to carvedilol or other β blockers
- Significant, persistent bradycardia (resting heart rate < 50 bpm) or hypotension (systolic blood pressure < 100 mmHg or mean blood pressure < 70 mmHg) at the time of enrollment
- Second or third-degree AV (Atrial Ventricular) block without pacemaker
- Use of CYP2D6 isoenzyme inhibitors (such as quinidine, fluoxetine, paroxetine, propafenone) which increase drug levels and result in greater vasodilating effects and hypotension
- Use of hypotensive drugs that deplete catecholamines (such as reserpine and monoamine oxidase inhibitors) which may lead to greater signs of hypotension or bradycardia
- Other medical and psychosocial conditions as determined by principal investigator deemed unsuitable for enrollment
Data sourced from ClinicalTrials.gov (NCT01586156). 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.