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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964678
• Other study ID #: HM12120
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 24, 2009
• Last updated: June 6, 2017
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2017
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Carvedilol
twice daily oral treatment in escalating dose

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Right Ventricular Ejection Fraction	Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only	baseline, 6 months
Secondary	Change in Right Ventricular End Systolic Volume	right ventricular end systolic volume determined by MRI	baseline and 6 months
Secondary	Change in 6 Minute Walk Distance		baseline and 6 months
Secondary	Change in Tricuspid Annular Plane Systolic Excursion	Higher values indicate a better outcome.	baseline and 6 months