INTRODUCTION: The effects of angiotensin converting enzyme inhibitor on systemic right ventricular size and function are unknown. METHODS: Prospective, double blind, randomized, placebo-controlled clinical trial of 1-year therapy with Ramipril in adult patients with DTGA status postatrial baffle procedure. Primary endpoints were change in systemic right ventricular ejection fraction (RVEF) and right ventricular size assessed by magnetic resonance imaging (MRI). RESULTS:Seventeen patients were enrolled into the study. Mean age at study enrollment was 26.4+/-5.2 years. Mean baseline RVEF was 44+/-6.5%, mean RVEDV was 206.3+/-75.5 ml. Eight patients were randomized to the treatment group and 9 patients were randomized to the placebo group. RVEF did not improve in the Ramipril group from baseline to 1 year (43.8+/-7.1% vs. 40.9+/-13.3%, p=0.52) and remain unchanged in the placebo group (44.3+/-6.3 vs. 46.3+/-9.6%, p=0.42). RVEDV (184.5+/-56.4 ml vs. 179.6+/-66.4 ml, p=0.64) and RVESV (109.5+/-19.4 ml vs. 111.8+/-30.1, p=0.74) remained unchanged in the Ramipril group from baseline to 1 year as well as in the placebo group (228.1+/-89.2 ml vs. 204.5+/-50.4 ml, p=0.42 and 117.5+/-36.9 ml vs. 117.4+/-26.2 ml, p=0.99, respectively). CONCLUSION: One-year treatment with Ramipril does not seem to affect right ventricular function or size in adult patients with systemic right ventricles after a Mustard or Senning procedure. CONDENSED ABSTRACT: 17 Adult patients (mean age of 26.4 +/- 5.2 years) with systemic right ventricles were blindly randomized to 1-year treatment with Ramipril placebo. Systemic right ventricular function (RVEF) and size (RVEDV) were assessed by magnetic resonance imaging at baseline and 1 year. RVEF failed to improve in the Ramipril group (43.8+/-7.1% vs. 40.9+/-13.3%, p=0.52) and remain unchanged in the placebo group (44.3+/-6.3 vs. 46.3+/-9.6%, p=0.42). RVEDV remained unchanged in the study group (184.5+/-56.4 ml vs. 179.6+/-66.4 ml, p=0.64 as well as in the placebo group (228.1 +/- 89.2 ml vs. 204.5 +/- 50.4 ml, p = 0.42). One-year treatment with Ramipril does not improve right ventricular function or attenuate remodeling in adult patients with systemic right ventricles.
RCT Entities:
INTRODUCTION: The effects of angiotensin converting enzyme inhibitor on systemic right ventricular size and function are unknown. METHODS: Prospective, double blind, randomized, placebo-controlled clinical trial of 1-year therapy with Ramipril in adult patients with DTGA status postatrial baffle procedure. Primary endpoints were change in systemic right ventricular ejection fraction (RVEF) and right ventricular size assessed by magnetic resonance imaging (MRI). RESULTS: Seventeen patients were enrolled into the study. Mean age at study enrollment was 26.4+/-5.2 years. Mean baseline RVEF was 44+/-6.5%, mean RVEDV was 206.3+/-75.5 ml. Eight patients were randomized to the treatment group and 9 patients were randomized to the placebo group. RVEF did not improve in the Ramipril group from baseline to 1 year (43.8+/-7.1% vs. 40.9+/-13.3%, p=0.52) and remain unchanged in the placebo group (44.3+/-6.3 vs. 46.3+/-9.6%, p=0.42). RVEDV (184.5+/-56.4 ml vs. 179.6+/-66.4 ml, p=0.64) and RVESV (109.5+/-19.4 ml vs. 111.8+/-30.1, p=0.74) remained unchanged in the Ramipril group from baseline to 1 year as well as in the placebo group (228.1+/-89.2 ml vs. 204.5+/-50.4 ml, p=0.42 and 117.5+/-36.9 ml vs. 117.4+/-26.2 ml, p=0.99, respectively). CONCLUSION: One-year treatment with Ramipril does not seem to affect right ventricular function or size in adult patients with systemic right ventricles after a Mustard or Senning procedure. CONDENSED ABSTRACT: 17 Adult patients (mean age of 26.4 +/- 5.2 years) with systemic right ventricles were blindly randomized to 1-year treatment with Ramipril placebo. Systemic right ventricular function (RVEF) and size (RVEDV) were assessed by magnetic resonance imaging at baseline and 1 year. RVEF failed to improve in the Ramipril group (43.8+/-7.1% vs. 40.9+/-13.3%, p=0.52) and remain unchanged in the placebo group (44.3+/-6.3 vs. 46.3+/-9.6%, p=0.42). RVEDV remained unchanged in the study group (184.5+/-56.4 ml vs. 179.6+/-66.4 ml, p=0.64 as well as in the placebo group (228.1 +/- 89.2 ml vs. 204.5 +/- 50.4 ml, p = 0.42). One-year treatment with Ramipril does not improve right ventricular function or attenuate remodeling in adult patients with systemic right ventricles.
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