Document Detail

Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation: the APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot).
MedLine Citation:
PMID:  20970202     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Optimal treatment for stable repaired tetralogy of Fallot (rTOF) patients with pulmonary regurgitation (PR) and related right ventricular (RV) dilatation, including timing of valve implantation, remains uncertain. We sought to study tolerability of the angiotensin-converting-enzyme (ACE) inhibitor ramipril and its effects on cardiovascular function in these patients.
METHODS: Clinically stable rTOF patients with moderate/severe PR were included. A double-blinded, placebo-controlled study of 6 months of ramipril vs placebo was performed. All patients underwent cardiovascular magnetic resonance (CMR), echocardiography, neurohormonal analysis, and objective cardiopulmonary exercise testing at baseline and follow-up.
PRIMARY ENDPOINT: The main aim was to detect changes in RV function (primary endpoint CMR-derived RV ejection fraction).
RESULTS: Seventy-two patients were enrolled and 64 qualified for the final analysis. There was no difference in the primary endpoint RV ejection fraction. RV long-axis shortening significantly improved in the ramipril group compared to placebo (RV: 2.3 ± 3.8 vs 0.02 ± 2.7 mm; P=0.017) as did LV long-axis shortening (1.9 ± 4.5 vs -0.2 ± 3.7 mm respectively; P=0.030). No clear differences were detected between ramipril and placebo for other measures. In a subgroup of patients with restrictive RV physiology, ramipril resulted in decrease in LV end-systolic volume index and increase in LVEF (-2.4 ± 5.0 vs 2.7 ± 3.6 mL/m(2); P=0.005, 2.5 ± 5.0 vs -1.3 ± 3.5%; P=0.03). Ramipril did not cause adverse events and was well tolerated.
CONCLUSIONS: Ramipril is a well tolerated therapy, improves biventricular function in patients with rTOF and may have a particular role in patients with restrictive RV physiology. Larger, longer-term studies are needed to determine if ACE inhibitors can improve both ventricular remodelling and clinical outcomes. (
ISRCTN: 97515585).
Sonya V Babu-Narayan; Anselm Uebing; Periklis A Davlouros; Michael Kemp; Simon Davidson; Konstantinos Dimopoulos; Stephanie Bayne; Dudley J Pennell; Derek G Gibson; Marcus Flather; Philip J Kilner; Wei Li; Michael A Gatzoulis
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-10-22
Journal Detail:
Title:  International journal of cardiology     Volume:  154     ISSN:  1874-1754     ISO Abbreviation:  Int. J. Cardiol.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-01-20     Completed Date:  2013-01-29     Revised Date:  2014-11-13    
Medline Journal Info:
Nlm Unique ID:  8200291     Medline TA:  Int J Cardiol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  299-305     Citation Subset:  IM    
Copyright Information:
Copyright © 2010. Published by Elsevier Ireland Ltd.
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MeSH Terms
Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
Double-Blind Method
Feasibility Studies
Prospective Studies
Pulmonary Valve Insufficiency / complications*,  physiopathology
Ramipril / therapeutic use*
Tetralogy of Fallot / complications*,  physiopathology,  surgery
Time Factors
Ventricular Function / drug effects*
Grant Support
PG/02/027//British Heart Foundation
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; L35JN3I7SJ/Ramipril

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