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Effect of pharmacological treatment with angiotensin receptor/neprilysin inhibitors on transthyretin cardiac amyloidosis and heart failure with reduced ejection fraction
EU CTIS ID: 2024-515661-34-00
What this study is testing
The primary objective is to determine the impact of treatment with Sacubitril/Valsartan on systolic function in patients with transthyretin amyloid cardiomyopathy and heart failure with reduced ejection fraction, by assessing the change in left ventricular ejection fraction in echocardiogram at 12 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18 years of age of both sexes.
- Patients diagnosed with transthyretin amyloid cardiomyopathy, both in its hereditary form (ATTRv) or wild-type form (ATTRwt). The diagnosis of ATTR will be based on histological demonstration of TTR amyloid deposition or non-invasive criteria as indicated in guidelines. For ATTRv diagnosis, demonstration of causal TTR mutation through genetic testing will be required.
- Patients initially evaluated or under follow-up in Cardiomyopathy/Heart Failure/Amyloidosis Units at participating centers.
- Presenting with heart failure and reduced ejection fraction: LVEF ≤45%, in functional class I, II, or III according to the New York Heart Association (NYHA).
You likely can't join if
- 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 <100 mmHg on two consecutive measurements.
- Treatment with ACE inhibitors (IECA), angiotensin II receptor blockers (ARAII), or sacubitril/valsartan at the time of enrollment.
- History of angioedema or hypersensitivity to ACE inhibitors or angiotensin II receptor blockers.
See the full eligibility criteria
- Patients ≥ 18 years of age of both sexes.
- Patients diagnosed with transthyretin amyloid cardiomyopathy, both in its hereditary form (ATTRv) or wild-type form (ATTRwt). The diagnosis of ATTR will be based on histological demonstration of TTR amyloid deposition or non-invasive criteria as indicated in guidelines. For ATTRv diagnosis, demonstration of causal TTR mutation through genetic testing will be required.
- Patients initially evaluated or under follow-up in Cardiomyopathy/Heart Failure/Amyloidosis Units at participating centers.
- Presenting with heart failure and reduced ejection fraction: LVEF ≤45%, in functional class I, II, or III according to the New York Heart Association (NYHA).
- 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 <100 mmHg on two consecutive measurements.
- Treatment with ACE inhibitors (IECA), angiotensin II receptor blockers (ARAII), or sacubitril/valsartan at the time of enrollment.
- History of angioedema or hypersensitivity to ACE inhibitors or angiotensin II receptor blockers.
- Treatment with diflunisal.
- Participation in another clinical trial or any condition that, in the investigator's opinion, compromises participation in the study.
- Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.