Carvedilol PAH A Pilot Study of Efficacy and Safety
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|ClinicalTrials.gov Identifier: NCT02120339|
Recruitment Status : Terminated (Low enrollment)
First Posted : April 22, 2014
Last Update Posted : July 12, 2019
Estimate the effect of chronic beta-adrenergic receptor blockade with carvedilol on RV function in patients with PAH.
Assess the safety and tolerability of chronic carvedilol therapy in patients with PAH
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Cardiac MRI <40||Drug: Carvedilol||Phase 1|
This is a prospective, open label, uncontrolled, pilot study examining the safety and efficacy of beta-blocker therapy with carvedilol on RV function in stable PAH Patients with World Health Organization (WHO) functional class II or III symptoms and RV ejection fraction (EF) < 40%. Twenty-five evaluable patients will be enrolled at the University of Minnesota.
1.1 Primary Efficacy Endpoint: Adult males and females on a stable dose of an approved PAH medication will undergo cardiac magnetic resonance imaging (MRI), right heart catheterization (RHC), echocardiogram, 6-minute walk test (6-MWT), measurement of plasma NT-ProBNP and serum catecholamine, and quality of life assessment. Patients will receive carvedilol (3.25 mg/kg bid escalating to 25 mg/kg bid over 3 months). Testing is repeated at the end of the study (month 6). RVEF measured by cardiac MRI is the primary efficacy endpoint. We define a 5% increase in RVEF as a meaningful change.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Beta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and Safety|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2016|
Carvedilol 0-3.125 mg daily Escalating to 6.25 twice a day
- Mean change in RVEF [ Time Frame: Baseline and 6 months ]1. The primary efficacy outcome is the mean change in RVEF as measured by cardiac MRI before and after 6 months of carvedilol treatment. An improvement of 5% will be considered to be clinically significant. Assessment of the RV is challenging due to its complex geometry. Cardiac MRI offers the ability to acquire 3-dimensional datasets that do not require geometric modeling. In addition to being highly reproducible40, RVEF measured by cardiac MRI can be used to identify PAH patients that are likely to have clinical worsening41. The prognostic ability of cardiac MRI-measurements of RVEF is similar to that as mean pulmonary artery pressure and exercise capacity
- Absence of Adverse Events [ Time Frame: 6 months ]The primary safety outcome is the absence of adverse events associated with carvedilol including hypotension (<90 mm Hg), bradycardia (<50 bpm or advanced atrioventricular nodal block), bronchospam, or acute decompensated right heart failure requiring hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120339
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Thenappan Thenappan, MD||University of Minnesota - Clinical and Translational Science Institute|