2024-514111-10-00招募中4 期
ARETHA: cARdiomems vEriciguaT Heart fAilure (A double-blind randomized placebo-controlled trial of vericiguat in heart failure patients with CardioMEMS™ HF System)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- To evaluate the diastolic pulmonary artery pressure (dPAP) lowering effect of vericiguat in comparison to placebo
研究概览
简要总结
Investigate the effect of vericiguat in patients with heart failure with reduced ejection fraction (HFrEF)
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
- •18 years or older
- •Ability to provide informed consent
- •CardioMEMS implanted for clinical indication (≥ 2 weeks prior to first visit)
- •Known chronic heart failure (HF) with left ventricular ejection fraction (LVEF) <45% (documented within the past 24 months by an imaging modality: echocardiography, nuclear imaging, LV angiography, or magnetic resonance imaging)
- •NYHA functional class II-IV symptoms.
- •Optimal and stable medical therapy for HF (as indicated under point 5 of exclusion criteria)
- •Systolic blood pressure (SBP) ≥100 mmHg
- •Diastolic pulmonary artery pressure (dPAP) >15 mmHg more than 8 days in the last 14 days on the CardioMEMS system.
排除标准
- •Patients in optimization phase in the CardioMEMS system or implantation of the CardioMEMs device within the past 2 weeks
- •Implantation of CRT device within the previous 90 days
- •Known allergy or sensitivity to any sGC stimulator
- •Primary valvular heart disease requiring surgery or intervention or is within 3 months after valvular surgery or intervention
- •Diagnosed with hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or takotsubo cardiomyopathy
- •Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia
- •Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [STEMI] or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days, or indication for coronary revascularization at first study visit
- •Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days
- •Complex congenital heart disease
- •Active endocarditis or constrictive pericarditis
- •eGFR <15 mL/min/1.73 m2 or chronic dialysis
- •Recent (within 14 days) hospitalization for decompensated HF
- •Severe hepatic insufficiency such as with hepatic encephalopathy
- •Malignancy or other non-cardiac condition limiting life expectancy to <1 years
- •Require continuous home oxygen for severe pulmonary disease
- •Current alcohol and/or drug abuse
- •Participating in another interventional clinical study or plans to participate in any other trial/investigation during the duration of this study
- •Mental or legal incapacitation and is unable to provide informed consent
- •Immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is involved with this study
- •Interstitial Lung Disease
- •Pregnant or breastfeeding (or lactating) or plans to become pregnant or to breastfeed during the course of the study
- •Women of reproductive age and childbearing potential not using at least one safe form of contraception
- •Average supine SBP <100 mmHg at the screening or randomization visit
- •Current symptomatic hypotension
- •Recent changes (within 48 hours) in diuretic dose, recent (within 4 weeks) initiation of hydralazine, long-acting nitrates, β-blockers, ACEi/ARB or ARNi.
- •Marked variability in PA diastolic pressure during screening period
- •Low CardioMEMS reading compliance (<75% 30 days reading compliance)
- •Concurrent or anticipated use of (1) long-acting nitrates or nitric oxide (NO) doners including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine, (2) sGC stimulators such as riociguat, (3) PDE5 inhibitors such as vardenafil, tadalafil, and sildenafil or (4) intravenous inotropes
- •Previous or planned LVAD or HTx implantation
结局指标
主要结局
To evaluate the diastolic pulmonary artery pressure (dPAP) lowering effect of vericiguat in comparison to placebo
To evaluate the diastolic pulmonary artery pressure (dPAP) lowering effect of vericiguat in comparison to placebo
次要结局
- To evaluate the NT-proBNP reducing effect of vericiguat compared with placebo
研究者
Sponsor and principal investigator
Scientific
Rigshospitalet
研究点 (3)
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