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NCT06712030Not yet recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 2 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
114 (estimated)
First submitted
19 Nov 2024
Start date
Jan 2025
Primary completion date
Apr 2027
Lead sponsor
Puerta de Hierro University Hospital
NCT number
NCT06712030
EU CT number
2024-515661-34-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 114
  • From Jan 2025 to the primary completion date, Apr 2027
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with ACE inhibitors, ARBs, or sacubitril/valsartan at the time of enrollment.
  • Treatment with TTR gene silencers or diflunisal.

Other illness

  • History of angioedema or hypersensitivity to ACE inhibitors or ARBs.
  • Any condition that, in the investigator's opinion, compromises participation in the study.

Lab values

  • 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).

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainRecruiting
Hospital Universitario Donostia
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DonostiaSpainRecruiting
Bellvitge University Hospital
Coordinator of this site? Confirm its status
L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
Coordinator of this site? Confirm its status
MajadahondaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.