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Clinical Trials in Spain / NCT06712030
Starting soon Phase 3

Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction

NCT06712030 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2025-01
Last updated
2024-12-02

Condition(s) studied

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Investigational drug(s) / intervention(s)

Sacubitril / Valsartan →

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)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Puerta de Hierro Majadahonda Madrid

More Puerta de Hierro University Hospital trials in Spain

Official registry record

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.

View NCT06712030 on ClinicalTrials.gov ↗ ← All trials in Spain