sacubitril, valsartan for Arrhythmogenic right ventricular cardiomyopathy

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- contraindications for CMR: - claustrophobia - cochlear implant - ferromagnetic material in tissues\n- symptoms of end-stage right ventricular failure (dyspnoea, massive peripheral edema, enlargement of the liver and abdominal circumference, positive jugular vein pulsation)\n- 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."}

Primary endpoints

• {"endpoint_text":"- the degree of fibrosis of the left ventricular muscle in the CMR examination","definition_or_measurement_approach":"Assessed by CMR (cardiac magnetic resonance) imaging as stated in the endpoint description."}
• {"endpoint_text":"- left ventricular ejection fraction (LVEF) in CMR","definition_or_measurement_approach":"Measured by CMR (cardiac magnetic resonance) imaging."}
• {"endpoint_text":"- ventricular arrhythmias load","definition_or_measurement_approach":"Not explicitly defined in the primary endpoint text; arrhythmia burden is assessed in secondary endpoints by ECG, 24-hour Holter, ergospirometry and ICD readings."}

Secondary endpoints

• {"endpoint_text":"- NT-proBNP concentration and two fibrosis markers: sST2 and Gal-3","definition_or_measurement_approach":"Measured by blood assays (biomarker concentrations) as stated."}
• {"endpoint_text":"- morphological and functional criteria (ECHO and CMR): the size of the left and right ventricles as well as generalized and focal contractility disorders","definition_or_measurement_approach":"Assessed by echocardiography (ECHO) and cardiac magnetic resonance (CMR)."}
• {"endpoint_text":"- ECG: terminal activation delay (TAD) and extent of negative T waves in precordial leads","definition_or_measurement_approach":"Measured by standard 12-lead ECG."}
• {"endpoint_text":"- arrhythmias in the ECG, 24-hour Holter ECG recording, ergospirometry and ICD readings","definition_or_measurement_approach":"Assessed using ECG, 24-hour Holter monitoring, ergospirometry tests and ICD device readouts."}
• {"endpoint_text":"- physical capacity (pVO2) assessed on the basis of ergospirometric tests","definition_or_measurement_approach":"Measured as pVO2 during ergospirometric (cardiopulmonary exercise) testing."}
• {"endpoint_text":"- hospitalization for symptoms of heart failure","definition_or_measurement_approach":"Clinical event adjudication of hospital admissions for heart failure symptoms."}
• {"endpoint_text":"- sudden cardiac death","definition_or_measurement_approach":"Clinical event (death) classification for sudden cardiac death."}

Poland

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

09-05-2025

Processing Time Days

231

Number Of Sites

8

Number Of Participants

120

Primary sponsor

Full Name

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Scientia Research Institute Sp. z o.o.","duties_or_roles":"codes: 1,12,5,6,8","organisation_type":"Pharmaceutical company"}