M. Albertini , V. Waldmann , P. David , A. Barat , A.S. Chaussade , L. Iserin , M. Ladouceur
{"title":"达帕格列净对全身性右心室功能障碍患者的安全性和有效性：初步结果","authors":"M. Albertini , V. Waldmann , P. David , A. Barat , A.S. Chaussade , L. Iserin , M. Ladouceur","doi":"10.1016/j.acvd.2024.07.011","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Heart failure (HF) is the leading cause of death in adults with a systemic right ventricle (sRV). Dapagliflozin has been shown to reduce hospitalization for HF and all-cause death in patients with HF and reduced ejection fraction. The impact of dapagliflozin in patients with a sRV remains unknown.</p></div><div><h3>Objective</h3><p>We aimed to evaluate the efficacy and safety of dapagliflozin in patients with sRV.</p></div><div><h3>Methods</h3><p>This was a prospective, observational, single-center study. All symptomatic (NYHA<!--> <!-->≥<!--> <!-->2) patients with a sRV dysfunction despite optimal medical treatment were included from March 2023 to March 2024. Patients were assessed at baseline and 3, 6 and 12<!--> <!-->months after dapagliflozin introduction. The primary endpoint was the 6-minute walk distance. Secondary endpoints included NT-proBNP, quality of life (KCCQ-12), NYHA class, systemic and sub-pulmonary ventricular systolic function, and potential treatment-related side effects.</p></div><div><h3>Expected results</h3><p>A total of 32 patients were included. Mean age was 48<!--> <!-->years (range: 19–79), 20 (62%) of patients were male, 12 (38%) had congenitally corrected transposition of the great arteries and 20 (62%) had transposition of the great arteries with atrial switch. Preliminary results at 6<!--> <!-->months were available in 20 patients. There was no statistically significant improvement in 6-minute walk distance (558.0<!--> <!-->m vs. 599.5, <em>P</em> <!-->=<!--> <!-->0.11) nor NT-proBNP (355.5<!--> <!-->pg/mL vs. 293.5, <em>P</em> <!-->=<!--> <!-->0.81). However, the quality of life of patients (80.5 vs. 92.0, <em>P</em> <!--><<!--> <!-->0.01) and the right ventricle global longitudinal strain (−11.2% vs. −12.9, <em>P</em> <!--><<!--> <!-->0.01) significantly improved. The drug was well tolerated with no side effects reported (<span><span>Fig. 1</span></span>).</p></div><div><h3>Perspectives</h3><p>These preliminary results suggest that dapagliflozin is well tolerated and associated with improved quality of life and right ventricle global longitudinal strain in patients with sRV dysfunction. Final results will bring important data on long-term outcomes associated with dapagliflozin use in this population.</p></div>","PeriodicalId":55472,"journal":{"name":"Archives of Cardiovascular Diseases","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of dapagliflozin in patients with systemic right ventricular dysfunction: Preliminary results\",\"authors\":\"M. Albertini , V. Waldmann , P. David , A. Barat , A.S. Chaussade , L. Iserin , M. Ladouceur\",\"doi\":\"10.1016/j.acvd.2024.07.011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Heart failure (HF) is the leading cause of death in adults with a systemic right ventricle (sRV). Dapagliflozin has been shown to reduce hospitalization for HF and all-cause death in patients with HF and reduced ejection fraction. The impact of dapagliflozin in patients with a sRV remains unknown.</p></div><div><h3>Objective</h3><p>We aimed to evaluate the efficacy and safety of dapagliflozin in patients with sRV.</p></div><div><h3>Methods</h3><p>This was a prospective, observational, single-center study. All symptomatic (NYHA<!--> <!-->≥<!--> <!-->2) patients with a sRV dysfunction despite optimal medical treatment were included from March 2023 to March 2024. Patients were assessed at baseline and 3, 6 and 12<!--> <!-->months after dapagliflozin introduction. The primary endpoint was the 6-minute walk distance. Secondary endpoints included NT-proBNP, quality of life (KCCQ-12), NYHA class, systemic and sub-pulmonary ventricular systolic function, and potential treatment-related side effects.</p></div><div><h3>Expected results</h3><p>A total of 32 patients were included. Mean age was 48<!--> <!-->years (range: 19–79), 20 (62%) of patients were male, 12 (38%) had congenitally corrected transposition of the great arteries and 20 (62%) had transposition of the great arteries with atrial switch. Preliminary results at 6<!--> <!-->months were available in 20 patients. There was no statistically significant improvement in 6-minute walk distance (558.0<!--> <!-->m vs. 599.5, <em>P</em> <!-->=<!--> <!-->0.11) nor NT-proBNP (355.5<!--> <!-->pg/mL vs. 293.5, <em>P</em> <!-->=<!--> <!-->0.81). However, the quality of life of patients (80.5 vs. 92.0, <em>P</em> <!--><<!--> <!-->0.01) and the right ventricle global longitudinal strain (−11.2% vs. −12.9, <em>P</em> <!--><<!--> <!-->0.01) significantly improved. The drug was well tolerated with no side effects reported (<span><span>Fig. 1</span></span>).</p></div><div><h3>Perspectives</h3><p>These preliminary results suggest that dapagliflozin is well tolerated and associated with improved quality of life and right ventricle global longitudinal strain in patients with sRV dysfunction. Final results will bring important data on long-term outcomes associated with dapagliflozin use in this population.</p></div>\",\"PeriodicalId\":55472,\"journal\":{\"name\":\"Archives of Cardiovascular Diseases\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Cardiovascular Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1875213624002328\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Cardiovascular Diseases","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1875213624002328","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Safety and efficacy of dapagliflozin in patients with systemic right ventricular dysfunction: Preliminary results
Introduction
Heart failure (HF) is the leading cause of death in adults with a systemic right ventricle (sRV). Dapagliflozin has been shown to reduce hospitalization for HF and all-cause death in patients with HF and reduced ejection fraction. The impact of dapagliflozin in patients with a sRV remains unknown.
Objective
We aimed to evaluate the efficacy and safety of dapagliflozin in patients with sRV.
Methods
This was a prospective, observational, single-center study. All symptomatic (NYHA ≥ 2) patients with a sRV dysfunction despite optimal medical treatment were included from March 2023 to March 2024. Patients were assessed at baseline and 3, 6 and 12 months after dapagliflozin introduction. The primary endpoint was the 6-minute walk distance. Secondary endpoints included NT-proBNP, quality of life (KCCQ-12), NYHA class, systemic and sub-pulmonary ventricular systolic function, and potential treatment-related side effects.
Expected results
A total of 32 patients were included. Mean age was 48 years (range: 19–79), 20 (62%) of patients were male, 12 (38%) had congenitally corrected transposition of the great arteries and 20 (62%) had transposition of the great arteries with atrial switch. Preliminary results at 6 months were available in 20 patients. There was no statistically significant improvement in 6-minute walk distance (558.0 m vs. 599.5, P = 0.11) nor NT-proBNP (355.5 pg/mL vs. 293.5, P = 0.81). However, the quality of life of patients (80.5 vs. 92.0, P < 0.01) and the right ventricle global longitudinal strain (−11.2% vs. −12.9, P < 0.01) significantly improved. The drug was well tolerated with no side effects reported (Fig. 1).
Perspectives
These preliminary results suggest that dapagliflozin is well tolerated and associated with improved quality of life and right ventricle global longitudinal strain in patients with sRV dysfunction. Final results will bring important data on long-term outcomes associated with dapagliflozin use in this population.
期刊介绍：
The Journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles and editorials. Topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.
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