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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00964678
• Date of registration: 24/08/2009
• Prospective Registration: Yes
• Primary sponsor: Virginia Commonwealth University
• Public title: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
• Scientific title: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
• Date of first enrolment: June 2010
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00964678
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Daniel C Grinnan, M.D
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion 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 (<3 months) treatment with an intravenous positive inotropic agent

- current use of ß-blockers

- history of reactive airways disease

- history of adverse reaction to ß-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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Carvedilol

Primary Outcome(s)

Absolute Change in Right Ventricular Ejection Fraction [Time Frame: baseline, 6 months]

Secondary Outcome(s)

Change in Right Ventricular End Systolic Volume [Time Frame: baseline and 6 months]

Change in Tricuspid Annular Plane Systolic Excursion [Time Frame: baseline and 6 months]

Change in 6 Minute Walk Distance [Time Frame: baseline and 6 months]

Secondary ID(s)

HM12120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 08/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00964678