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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517412-29-00
Acronym
2021/ABM/01/00004
Enrollment
120
Registered
2024-10-31
Start date
2023-07-10
Completion date
Unknown
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arrhythmogenic in the old space of cardiomyopathy

Brief summary

the degree of fibrosis of the left ventricular muscle in the CMR examination, left ventricular ejection fraction (LVEF) in CMR, ventricular arrhythmias load

Detailed description

NT-proBNP concentration and two fibrosis markers: sST2 and Gal-3, morphological and functional criteria (ECHO and CMR): the size of the left and right ventricles as well as generalized and focal contractility disorders, ECG: terminal activation delay (TAD) and extent of negative T waves in precordial leads, arrhythmias in the ECG, 24-hour Holter ECG recording, ergospirometry and ICD readings, physical capacity (pVO2) assessed on the basis of ergospirometric tests, hospitalization for symptoms of heart failure, sudden cardiac death

Interventions

Sponsors

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
the degree of fibrosis of the left ventricular muscle in the CMR examination, left ventricular ejection fraction (LVEF) in CMR, ventricular arrhythmias load

Secondary

MeasureTime frame
NT-proBNP concentration and two fibrosis markers: sST2 and Gal-3, morphological and functional criteria (ECHO and CMR): the size of the left and right ventricles as well as generalized and focal contractility disorders, ECG: terminal activation delay (TAD) and extent of negative T waves in precordial leads, arrhythmias in the ECG, 24-hour Holter ECG recording, ergospirometry and ICD readings, physical capacity (pVO2) assessed on the basis of ergospirometric tests, hospitalization for symptoms of heart failure, sudden cardiac death

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026