Authorised Therapeutic confirmatory (Phase III) arrhythmogenic in the old space of cardiomyopathy

Sacubitril/valsartan in the prevention of disease progression in patients with an ancient arrhythmogenic service - ARNI-ARVC multicentre randomized trial

EU CTIS ID: 2024-517412-29-00

What this study is testing

The aim of the ARNI-ARVC study is to assess the anti-fibrotic and antiremodeling effects of sacubitril / valsartan in ARVC.

  • Therapeutic confirmatory (Phase III)

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

  • certain diagnosis of ARVC based on the 2010 International Task Force Criteria (ITFC) diagnostic criteria
  • age> 18 years
  • expressing a written informed consent to participate in the project
  • Left ventricular ejection fraction (LVEF) ≥ 40% as assessed by CMR.

You likely can't join if

  • contraindications for CMR: - claustrophobia - cochlear implant - ferromagnetic material in tissues
  • symptoms of end-stage right ventricular failure (dyspnoea, massive peripheral edema, enlargement of the liver and abdominal circumference, positive jugular vein pulsation)
  • contraindications to the use of sacubitril / valsartan: - drug intolerance History of angioedema related to prior treatment with an angiotensin converting enzyme inhibitor or an angiotensin II receptor antagonist - hereditary or idiopathic angioedema - hyperkalaemia greater than 5.4 mmol / l - severe hepatic impairment - biliary cirrhosis and cholestasis - Child-Pugh grade C - renal failure with eGFR <30 ml / min / 1.73 m2 - hypersensitivity to the active substances or any of the excipients - taking direct renin inhibitors - pregnancy - lactation.

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.