Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of Sacubitril/Valsartan (Sac/Vals) compared to no initiation of the drug in patients with transthyretin cardiac amyloidosis (ATTR) and heart failure with reduced ejection fraction (LVEF ≤40%). The primary objective is to determine the impact of Sac/Vals treatment on systolic function by assessing the change in LVEF on echocardiogram at 12-month follow-up.
Patients ≥ 18 years of age of both sexes.
Patients diagnosed with ATTR cardiac amyloidosis as indicated in guidelines, both in its hereditary form (ATTRv) or wild-type form (ATTRwt).
Patients initially evaluated or under follow-up in Cardiomyopathy/Heart Failure/Amyloidosis Units at participating centers.
Heart failure and reduced ejection fraction: LVEF ≤40%, in functional class I, II, or III according to the New York Heart Association (NYHA).
NYHA Functional Class IV.
Stage 4 and 5 chronic kidney disease (creatinine clearance by CKD-EPI <30 mL/min/1.73m²).
Hyperkalemia (blood potassium levels > 5.4 mmol/L).
Hypotension defined as systolic blood pressure (SBP) <100 mmHg on two consecutive measurements.
Parallel
Sacubitril / Valsartan
DrugDose titration of Sacubitril/Valsartán to the maximum tolerated dose (maximum 97/103 mg)
Change in left ventricular systolic function (%) assessed by echocardiogram.
Measured by biplane method in percentage
Change in left ventricular systolic function assessed by global longitudinal strain (GLS)
Measure of longitudinal shortening as a percentage
Change in E/e' ratio measured by echocardiogram.
Ratio between E wave (peak velocity of early diastolic blood flow across the mitral valve, measured using transmitral Doppler) and E' (E prime): velocity of early diastolic mitral annular motion, measured using tissue Doppler imaging.
Change in functional capacity assessed by 6-minute walk test
Distance covered over a time of 6 minutes in a flat surface in meters.
Change in quality of life according to the Kansas City Cardiomyopathy Questionnaire
0 to 100 scale, where 0 is the worst possible health status and 100 best possible health status.
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