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ARETHA: cARdiomems vEriciguaT Heart fAilure (A double-blind randomized placebo-controlled trial of vericiguat in heart failure patients with CardioMEMS™ HF System)
EU CTIS ID: 2024-514111-10-00
What this study is testing
Investigate the effect of vericiguat in patients with heart failure with reduced ejection fraction (HFrEF)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.