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

Launched by PUERTA DE HIERRO UNIVERSITY HOSPITAL · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Sacubitril/Valsartan on patients with a specific heart condition known as transthyretin cardiac amyloidosis (ATTR-CM) and heart failure with reduced ejection fraction. This means their heart isn't pumping effectively, with a measurement called ejection fraction at 40% or less. The main goal of the study is to see if taking this medication can improve heart function over a 12-month period, as seen through ultrasound tests of the heart.

To participate in the trial, individuals must be at least 18 years old and diagnosed with either the hereditary or non-hereditary form of ATTR. They should be experiencing heart failure classified as functional class I, II, or III, meaning they have some limitations in physical activity but are not completely unable to perform normal activities. However, those with more severe heart failure, certain kidney issues, or who are currently taking specific heart medications will not be eligible. The trial is not yet recruiting participants, but once it begins, individuals who qualify can expect regular check-ups and monitoring to assess how their heart is responding to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • NYHA Functional Class IV.
• • 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.