Alexandra C van Dissel1, Michiel M Winter2, Teun van der Bom2, Hubert W Vliegen3, Arie P J van Dijk4, Petronella G Pieper5, Gertjan T Sieswerda6, Jolien W Roos-Hesselink7, Aeilko H Zwinderman8, Barbara J M Mulder1, Berto J Bouma9. 1. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Heart Center, Amsterdam, the Netherlands; Netherlands Heart Institute, Utrecht, the Netherlands. 2. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Heart Center, Amsterdam, the Netherlands. 3. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands. 4. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. 5. Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands. 6. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands. 7. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. 8. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands. 9. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Heart Center, Amsterdam, the Netherlands. Electronic address: b.j.bouma@amc.uva.nl.
Abstract
OBJECTIVES: In the VAL-SERVE (Valsartan in Systemic Right Ventricle) trial, three-year valsartan treatment improved systemic ventricular function only in symptomatic patients with congenitally or with an atrial switch corrected transposition of the great arteries. The aim of the current study was to investigate the longer-term clinical outcomes after valsartan treatment. METHODS:From 2006 to 2009, 88 adults were randomly allocated 1:1 to either valsartan or placebo for three consecutive years. Endpoints were defined as overall survival and freedom from clinical events (arrhythmia, heart failure, tricuspid valve surgery, death). RESULTS: Cardiac drug use and median follow-up after trial close-out (8.3 years) was similar between the randomization groups. Six patients (valsartan n = 3, placebon = 3) died in 364 and 365 person-years (P = 0.999). No difference in the composite or separate clinical endpoints was found between the randomization groups, with corresponding long-term event-free survival rates of 50% and 34%. Nevertheless, in symptomatic patients valsartan significantly reduced the risk for events compared to placebo (HR 0.37, 95% CI 0.17-0.92). Analysis for repeated events and on-treatment analysis with any renin-angiotensin-aldosterone-system-inhibitor did not alter these results. CONCLUSIONS:Valsartan treatment in systemic RV patients did not result in improved survival at longer-term follow-up, but was associated with decreased risk of events in symptomatic patients.
RCT Entities:
OBJECTIVES: In the VAL-SERVE (Valsartan in Systemic Right Ventricle) trial, three-year valsartan treatment improved systemic ventricular function only in symptomatic patients with congenitally or with an atrial switch corrected transposition of the great arteries. The aim of the current study was to investigate the longer-term clinical outcomes after valsartan treatment. METHODS: From 2006 to 2009, 88 adults were randomly allocated 1:1 to either valsartan or placebo for three consecutive years. Endpoints were defined as overall survival and freedom from clinical events (arrhythmia, heart failure, tricuspid valve surgery, death). RESULTS: Cardiac drug use and median follow-up after trial close-out (8.3 years) was similar between the randomization groups. Six patients (valsartan n = 3, placebo n = 3) died in 364 and 365 person-years (P = 0.999). No difference in the composite or separate clinical endpoints was found between the randomization groups, with corresponding long-term event-free survival rates of 50% and 34%. Nevertheless, in symptomatic patientsvalsartan significantly reduced the risk for events compared to placebo (HR 0.37, 95% CI 0.17-0.92). Analysis for repeated events and on-treatment analysis with any renin-angiotensin-aldosterone-system-inhibitor did not alter these results. CONCLUSIONS:Valsartan treatment in systemic RV patients did not result in improved survival at longer-term follow-up, but was associated with decreased risk of events in symptomatic patients.
Keywords:
Congenital heart disease; Heart failure; Long-term follow-up; Renin angiotensin aldosterone system; Systemic right ventricle; Transposition of the great arteries
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