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Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction
Sponsor: Puerta de Hierro University Hospital
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
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