2023-505048-20-00招募中2 期
BLOCKADE OF THE RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM IN PATIENTS WITH ARVD: A DOUBLE-BLIND MULTICENTRE PROSPECTIVE RANDOMIZED STUDY BRAVE
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 13
- 主要终点
- Right ventricular deterioration is defined by a decrease in RV longitudinal strain or/and increase of RV infundibulum diameter between baseline and 1 year of follow-up measured by echography. Ventricular arrhythmia is defined by the change in arrhythmia, defined as a number of occurrences of ventricular extrasystoles > 500 during a 24h-Holter ECG monitor test, between baseline and 1 year of follow-up
研究概览
简要总结
Evaluate the benefit of spironoclatone on the reduction of right ventricular deterioration and ventricular arrhythmia in patients with ARVD using echocardiography and 24h Holter-ECG.
研究设计
- 分配方式
- Randomized
- 主要目的
- Spironolactone/placebo
- 盲法
- Double (Investigator, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patient≥ 18 years
- •Diagnosis of ARVD based on Task Force criteria. Two major criteria: 1 morphologic and one rhythmic or 1 major and 2 minor criteria established by the European Society of Cardiology/International Society and Federation of Cardiology
- •Signed written informed consent
- •Patient on optimised medical treatment, including beta-blockers.
排除标准
- •Patients under judicial protection
- •Normal right ventricular volume
- •Heart transplantation
- •Swallowing disorders
- •Participation in any other interventional clinical investigation that may have an impact on our study
- •Female patient who is pregnant or lactating, or is of child bearing potential (defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if ≤ 55 years or 12 months if > 55 years) and who did not agree to use highly effective methods of birth control throughout the study.
- •No health insurance
- •Right heart failure patient (RV volume>150ml)
- •Spironolactone contraindication
- •Mandatory indication for a combination of ACE inhibitor and sartan or renin inhibitor (each authorized separately)
- •Acute phase of systemic disease
- •Uncompensated hypothyroidism
- •Acute hyperthyroidism
结局指标
主要结局
Right ventricular deterioration is defined by a decrease in RV longitudinal strain or/and increase of RV infundibulum diameter between baseline and 1 year of follow-up measured by echography. Ventricular arrhythmia is defined by the change in arrhythmia, defined as a number of occurrences of ventricular extrasystoles > 500 during a 24h-Holter ECG monitor test, between baseline and 1 year of follow-up
Right ventricular deterioration is defined by a decrease in RV longitudinal strain or/and increase of RV infundibulum diameter between baseline and 1 year of follow-up measured by echography. Ventricular arrhythmia is defined by the change in arrhythmia, defined as a number of occurrences of ventricular extrasystoles > 500 during a 24h-Holter ECG monitor test, between baseline and 1 year of follow-up
次要结局
- Ventricular arrhythmia is defined by number of ventricular extrasystoles during a 24h-Holter ECG monitor test, between baseline and 1 year of follow-up.
- Functional status is defined by presence/absence and number of palpitations, ventricular tachycardia, dyspnea, syncope, sudden death, thoracic pain, MACE, and hospital admissions owing to clinical deterioration during the 1 year of follow-up
- LV function (LV diameters, LV volumes, LVEF, LVGLS, presence of aneurism, % of dyskinesia), size of RV (LVOT diameters - PLAX and SAX, end-diastolique area, end-systolique area, 3D volumes), RV function (fractional shortening, presence of aneurism , % dyskinesia, TAPSE, tissue Doppler velocity, 3D RVEF, lateral longitudinal strain, global longitudinal strain) on echography between baseline and 1 year , and evolution of QRS width and PR duration on ECG between baseline and 1 year
- RV function (fractional shortening, presence of aneurism , % dyskinesia, TAPSE, tissue Doppler velocity, 3D RVEF, lateral longitudinal strain, global longitudinal strain) using echocardiography and arrhythmia burden using 24h Holter-ECG at 1 year of follow-up according to the genotype (No mutation versus, at least, one mutation on desmosome genes).
- Quantification of fibrosis and inflammation (measured at baseline and 1-year of follow-up) by dosage of MMP9, TIMP1, TIMP2, IL6 and IL8
- Ventricular arrhythmia is defined by number of ventricular extrasystoles during a 24h-Holter ECG monitor test, between baseline and 3 years of follow-up
- Functional status is defined by presence/absence and number of palpitations, ventricular tachycardia, dyspnea, syncope, sudden death, thoracic pain, MACE, and hospital admissions owing to clinical deterioration during the 3 years of follow-up.
- Left Ventricle (LV) function (LV diameters, LV volumes, LVEF, LVGLS, presence of aneurism, % of dyskinesia), size of RV (LVOT diameters - PLAX and SAX, end-diastolique area, end-systolique area, 3D volumes), RV function (fractional shortening, presence of aneurism , % dyskinesia, TAPSE, tissue Doppler velocity, 3D RVEF, lateral longitudinal strain, global longitudinal strain) on echography between baseline and 3 years, and evolution of QRS width and PR duration on ECG between baseline and 3 year
- RV function (fractional shortening, presence of aneurism , % dyskinesia, TAPSE, tissue Doppler velocity, 3D RVEF, lateral longitudinal strain, global longitudinal strain) using echocardiography and arrhythmia burden using 24h Holter-ECG at 3 years of follow-up according to the genotype (No mutation versus, at least, one mutation on desmosome genes).
- Quantification of fibrosis and inflammation (measured at baseline and 3 years of follow-up) by dosage of MMP9, TIMP1, TIMP2, IL6 and IL8.
研究者
Pr Chevalier
Scientific
Hospices Civils De Lyon
研究点 (13)
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