Tests sacubitril/valsartan in patients with transthyretin cardiac amyloidosis and weakened heart pumping
Tests sacubitril/valsartan in adults with transthyretin amyloid heart disease and reduced heart function.
Plain-language title generated from the registry record
Registry title: Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction
Key facts
- Where
- A Coruña, Barcelona, Ciudad Real, Donostia, L'hospitalet De Llobregat, Majadahonda, Salamanca, Santiago de Compostela, and Zaragoza, SpainSee the 9 sites
- Phase
- Phase 3
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital General Universitario de Ciudad RealCiudad Real, SpainTaking people
- Hospital Universitario DonostiaDonostia, SpainTaking people
- Bellvitge University HospitalL'hospitalet De Llobregat, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Puerta de Hierro University Hospital
- Trial code
- NCT06712030EU 2024-515661-34-00
- Record updated
- 2 December 2024
- Original description
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.Read full original descriptionShow less
Effect of Pharmacological Treatment with Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction (SAVA-TTR)
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.
Inclusion: 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: Treatment with ACE inhibitors, ARBs, or sacubitril/valsartan at the time of enrollment; Treatment with TTR gene silencers or diflunisal; History of angioedema or hypersensitivity to ACE inhibitors or ARBs; Any condition that, in the investigator's opinion, compromises participation in the study; 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); NYHA Functional Class IV; Hypotension defined as systolic blood pressure (SBP) <100 mmHg on two consecutive measurements; Participation in another clinical trial; Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.