Sacubitril/valsartan in preventing disease progression in patients with arrhythmogenic right ventricular cardiomyopathy

Team

prof. dr hab. n. med. Elżbieta Katarzyna Biernacka

Project Manager - Chief Researcher

dr n. med. Olgierd Woźniak

Researcher

Project value
Project value
Value of the Funding

Funding:

The project is funded by:
Medical Research Agency

Competition: ABM/2021/1
Project Number: :
2021/ABM/01/00004

Project Name:

Sacubitril/valsartan in preventing disease progression in patients with arrhythmogenic right ventricular cardiomyopathy – a multicenter randomized ARNI-ARVC study.

Project Description:

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a disease most often manifesting in young, seemingly healthy adults. The essence of the disease is the replacement of cardiomyocytes with fibrous and fatty tissue. It is a rare disease, mostly genetically conditioned. Currently, patients are symptomatically treated with antiarrhythmic drugs.

Sacubitril/valsartan is the only available drug from the ARNI (angiotensin receptor-neprilysin inhibitor) group, consisting of valsartan (angiotensin II receptor antagonist) and sacubitril.

The ARNI-ARVC study will include 100 ARVC patients. Recruitment will be conducted by 9 cardiology centers in Poland. Patients will be block-randomized at a 3:2 ratio to treatment with sacubitril/valsartan or to the control group.

For all patients, treatment with sacubitril/valsartan will start from the smallest available dose of the drug (24/26 mg twice/day), which after 6 weeks will be increased to the medium dose (49/51 mg twice/day), and after another 6 weeks to the target dose (97/103 mg twice/day). In case of intolerance to the increased drug dose, the study participant will continue treatment with the highest dose of sacubitril/valsartan tolerated by them. Each patient will be observed for 4 years.

The primary objective of the multicenter, randomized ARNI-ARVC study is to assess the antiremodeling and antifibrotic action of sacubitril/valsartan in ARVC, which would prevent disease progression and translate into clinical improvement: delay or prevent the onset of heart failure symptoms and reduce arrhythmias.

The study is funded by the state budget from the Medical Research Agency, Poland, Project Number: 2021/ABM/01/00004

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