PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01586156
• Date of registration: 23/04/2012
• Prospective Registration: Yes
• Primary sponsor: The Cleveland Clinic
• Public title: PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol) PAHTCH
• Scientific title: Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure
• Date of first enrolment: December 2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01586156
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Serpil Erzurum, MD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion 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 ß 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: placebo

Drug: Carvedilol

Primary Outcome(s)

Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography) [Time Frame: 6 months]

Secondary Outcome(s)

Beta-Adrenergic Receptor (Alprenolol Binding Assay) [Time Frame: 6 months]

Urinary cAMP (Cyclic Adenosine Monophosphate)/Creatinine [Time Frame: 6 months]

Secondary ID(s)

11-1198

R01HL115008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

Results

• Results available: Yes
• Date Posted: 30/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01586156