Effect of Angiotensin Receptor/Neprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction
NCT ID: NCT06712030
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
114 participants
INTERVENTIONAL
2025-01-31
2027-06-30
Brief Summary
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Detailed Description
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The investigators plan to conduct a prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of Sacubitril/Valsartan (Sac/Vals), as recommended in current HF guidelines, versus no treatment in patients with ATTR and heart failure with reduced ejection fraction (HFrEF), including those with LVEF ≤40%.
Approximately 114 patients from four Spanish centers will be randomized 1:1 to receive Sac/Vals treatment (up to the maximum tolerated dose) or to not initiate the drug, with stratification by center and tafamidis treatment. It has been included a run-in period with a low dose of Sac/Vals to assess tolerance prior to randomization. Patients will have scheduled follow-up visits at 3, 6, and 12 months, during which clinical, functional, analytical, electrocardiographic, and echocardiographic variables will be evaluated.
The primary objective is to determine the impact of Sac/Vals treatment on systolic function in patients with ATTR and HFrEF by assessing the change in LVEF on echocardiogram at 12 months. Improvement in LVEF will be defined as an increase of ≥5% from the baseline echocardiogram to the 12-month follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sacubitril/Valsartan
Sacubitril/valsartan up to maximum tolerated dose
Sacubitril / Valsartan
Dose titration of Sacubitril/Valsartán to the maximum tolerated dose (maximum 97/103 mg)
No treatment
No initiation of Sacubitril/valsartan
No interventions assigned to this group
Interventions
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Sacubitril / Valsartan
Dose titration of Sacubitril/Valsartán to the maximum tolerated dose (maximum 97/103 mg)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
* Hypotension defined as systolic blood pressure (SBP) \<100 mmHg on two consecutive measurements.
* Treatment with ACE inhibitors, ARBs, or sacubitril/valsartan at the time of enrollment.
* History of angioedema or hypersensitivity to ACE inhibitors or ARBs.
* Treatment with TTR gene silencers or diflunisal.
* Participation in another clinical trial.
* Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.
* Any condition that, in the investigator's opinion, compromises participation in the study.
18 Years
ALL
No
Sponsors
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Puerta de Hierro University Hospital
OTHER
Responsible Party
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Esther Gonzalez López
Principal Investigator
Principal Investigators
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Esther Gonzalez Lopez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain
Locations
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Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-515661-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-515661-34-00
Identifier Type: -
Identifier Source: org_study_id