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NOT YET RECRUITING
NCT06712030
PHASE3

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

Sponsor: Puerta de Hierro University Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Pharmacological Treatment with Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction (SAVA-TTR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-01

Completion Date

2027-06

Last Updated

2024-12-02

Healthy Volunteers

No

Interventions

DRUG

Sacubitril / Valsartan

Dose titration of Sacubitril/Valsartán to the maximum tolerated dose (maximum 97/103 mg)

Locations (1)

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain