Sacubitril / Valsartan: Dose titration of Sacubitril/Valsartán to the maximum tolerated dose (maximum 97/103 mg)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
* Treatment with ACE inhibitors, ARBs, or sacubitril/valsartan at the time of enrollment.
* History of angioedema or hypersensitivity to ACE inhibitors or ARBs.
* Treatment with TTR gene silencers or diflunisal.
* Participation in another clinical trial.
* Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.
* Any condition that, in the investigator's opinion, compromises participation in the study.
Primary outcome measure(s)
Change in left ventricular systolic function (%) assessed by echocardiogram. — 12 months Measured by biplane method in percentage
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario Puerta de Hierro
Majadahonda
Madrid
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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