The study enrolled 26 single-ventricle patients between 10-35 years old with a previous Fontan operation who were able to complete a maximal exercise test (respiratory exchange ratio [RER] >1.0). Two 12-week treatment arms were separated by a period of 6 weeks for drug washout. Exercise testing was performed at the beginning and end of each treatment arm. Study drug was increased to a goal maximum dose (0.2-0.3 mg/kg/dose twice daily). The primary study outcome was an improvement in peak oxygen consumption/kg (pVO2) from the baseline measurement.
Out of the 26 participants, 23 were able to complete the study. In the carvedilol arm, 4 subjects were unable to reach the maximum dose, as compared with a single participant in the placebo arm (P=0.14). The primary outcome was not met; the mean change in pVO2 between treatments was not different (-2.1 mL/kg/min in the carvedilol arm vs -1.42 in the placebo arm; P=0.28). The peak heart rate decreased in subjects taking carvedilol (P<0.01) leading to a subsequent increase in peak oxygen pulse (P<0.01). No differences were reported for ventilatory efficiency (slope of VE/VCO2 curves), oxygen uptake efficiency, or maximum work performed. Serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels increased with carvedilol (mean +23.77 pg/mL) compared with the placebo arm (mean -5.37 pg/mL; P=0.03).
No serious adverse events were observed in the carvedilol arm. Dr Butts concluded that carvedilol had a safe tolerability profile in the majority of subjects with Fontan physiology, despite not being associated with improved exercise performance. Furthermore, carvedilol was associated with mildly increased levels of NT-proBNP. In brief, this study suggests that there is no indication for carvedilol in healthy Fontan patients. The role of potential carvedilol therapy in Fontan patients with heart failure may warrant additional research.
1. Butts RJ, et al. Carvedilol Does Not Improve Exercise Performance in Fontan Patients: Results of a Cross Over Trial. FS.AOS.04, AHA Scientific Sessions 2019, 14-18 November, Philadelphia, USA.
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Table of Contents: AHA 2019
Featured articles
New Approaches to CVD Risk Reduction
Phase 3 BETonMACE trial did not meet its primary endpoint
Inclisiran safely halves LDL-Cholesterol
Colchicine prevents cardiovascular events
Interventional Management for Acute Coronary Syndrome
Drop aspirin after 3 months in non-STEMI ACS patients on dual antiplatelet therapy
Immediate coronary angiography after cardiac arrest does not improve survival
Complete revascularisation for obstructive non-culprit lesions with vulnerable plaque
Colchicine: no difference in peri-procedural cardiovascular events 30 days post-PCI
Intra-aortic balloon pump better than Impella: new observational data
Results for the Ischemia Trials: To Intervene or Not to Intervene
ISCHEMIA trial: Invasive treatment only better for angina burden
Controversies in Contemporary Management of Aortic Stenosis
Full GALILEO results: Why did rivaroxaban fail after TAVR?
Balloon-expandable better than self-expanding transcatheter heart valves
RECOVERY: Benefit of early surgery in asymptomatic severe aortic stenosis
Guidelines: Updates and Controversies
New guidelines on the prevention of cardiovascular conditions
Trials in Electrophysiology and Left Ventricular Function
RENAL-AF trial: Apixaban similar to warfarin
Apple Heart Study: Not just for atrial fibrillation
Early apixaban safe as secondary prevention of stroke from AF
Carvedilol does not improve exercise performance in Fontan patients
New Frontiers in Lipid Therapy
Icosapent ethyl plus statins reduces total plaque volume
ORION-9: Inclisiran RNAi halves LDL in familial hypercholesterolaemia patients
New RNAi therapies to reduce triglycerides: 2 studies show favourable results
Targeting LDL-C <70 mg/dL is better than 100 mg/dL after stroke
Challenges in Heart Failure Management
FUEL trial: Udenafil improves some exercise measurements in Fontan
DAPA-HF: Dapagliflozin also good for heart failure patients without diabetes, of any age, or any health status
PARAGON-HF: Benefits for women and lower ejection fraction
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