Table 2.

Endpoints collected during the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor vs Placebo in Patients With Congenital Systemic Right Ventricular Heart Failure Trial (PARACYS-RV)

Endpoints	Description	Visits of endpoints collection
Primary efficacy
Exercise capacity and neurohormonal activation	1) Submaximal total exercise duration 2) NT-proBNP level	At screening (V1) and at the end of each treatment arm (V9 and V14)
Secondary efficacy
Quality of life	Kansas City Cardiomyopathy Questionnaire	At screening (V1) and at the end of each treatment arm (V9 and V14)
Secondary safety
Safety of medication	Electrolytes (serum potassium level), renal function (creatinine, eGFR, urea), blood pressure Adverse clinical events occurred during each treatment arm: cough, postural symptoms, angioedema.	At screening (V1), at the halfway time point for each treatment arm (V8 and V13) and at the end of each treatment arm (V9 and V14). From screening (V1) until end of the follow-up (run in phase, 2 arms phases, and safety period)
Exploratory
NYHA functional class	NYHA class	At screening (V1) and at the end of each treatment arm (V9 and V14)
Occurrence of clinical events	Heart failure, hospitalizations, arrhythmias (supraventricular and ventricular), mortality	From screening (V1) until end of the follow-up (run in phase, 2 arms phases, and safety period)
Myocardial injury biomarker	High-sensitivity Troponin T level	At screening (V1) and at the end of each treatment arm (V9 and V14)
sRv-biV size and function	TAPSe, S’wave, fractional area change, global longitudinal strain, end diastolic area, end systolic area by transthoracic echocardiography	At screening (V1) and at the end of each treatment arm (V9 and V14)
Exercise capacity complementary parameters	Anaerobic threshold, functional capacity METs, heart rate response, blood pressure response, oxygen saturation during exercise, respiratory exchange ratio VE/VCO2 slope	At screening (V1) and at the end of each treatment arm (V9 and V14)
Metabolic profile	Lipidomic analysis	At screening (V1) and at the end of each treatment arm (V9 and V14)

eGFR, estimated glomerular filtration rate; MET, metabolic equivalent; NT-proBNP, N-terminal prohormone brain natriuretic peptide; NYHA, New York Heart Association; sRv-biV, systemic right ventricle with biventricular physiology; TAPSe, tricuspid annular plane systolic excursion; V, visit; VE/VCO2 slope, ventilation/carbon dioxide production slope.