Valsartan, Sacubitril for Transthyretin cardiac amyloidosis | Heart failure with reduced ejection fraction

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years of age of both sexes.\n- Patients diagnosed with transthyretin amyloid cardiomyopathy, both in its hereditary form (ATTRv) or wild-type form (ATTRwt). The diagnosis of ATTR will be based on histological demonstration of TTR amyloid deposition or non-invasive criteria as indicated in guidelines. For ATTRv diagnosis, demonstration of causal TTR mutation through genetic testing will be required.\n- Patients initially evaluated or under follow-up in Cardiomyopathy/Heart Failure/Amyloidosis Units at participating centers.\n- Presenting with heart failure and reduced ejection fraction: LVEF ≤45%, in functional class I, II, or III according to the New York Heart Association (NYHA)."}

Exclusion criteria

• {"criterion_text":"- NYHA Functional Class IV.\n- Stage 4 and 5 chronic kidney disease (creatinine clearance by CKD-EPI <30 mL/min/1.73m²).\n- Hyperkalemia (blood potassium levels > 5.4 mmol/L).\n- Hypotension defined as systolic blood pressure <100 mmHg on two consecutive measurements.\n- Treatment with ACE inhibitors (IECA), angiotensin II receptor blockers (ARAII), or sacubitril/valsartan at the time of enrollment.\n- History of angioedema or hypersensitivity to ACE inhibitors or angiotensin II receptor blockers.\n- Treatment with diflunisal.\n- Participation in another clinical trial or any condition that, in the investigator's opinion, compromises participation in the study.\n- Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration."}

Primary endpoints

• {"endpoint_text":"- Change in left ventricular ejection fraction (%), assessed by echocardiogram, compared to baseline value after 12-month treatment with Sacubitrl/Valsartan versus management without Sacubitril/Valsartan. An improvement in left ventricular ejection fraction will be defined as an increase of ≥ 5% between the baseline echocardiogram and the 12-month echocardiogram.","definition_or_measurement_approach":"Assessed by echocardiogram compared to baseline after 12 months; improvement defined as an increase of ≥ 5% between baseline and 12-month echocardiogram."}

Spain

Latest Decision Or Authorization Date

13-04-2026

Number Of Sites

9

Number Of Participants

114

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III (PI23/01180)","duties_or_roles":"Monetary support","organisation_type":""}