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
- Diseases
- Amyloidosis, Heart failure
- 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
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.