Sacubitril-Valsartan for Congenital Heart Disease
This study is looking at how a medication called Entresto (sacubitril-valsartan) affects the heart in adults with congenital heart disease (a heart problem present from birth). You would either take Entresto pills, starting with a lower dose and increasing over time, or a placebo (an inactive pill). Researchers want to see if Entresto can improve your heart's structure and how well it pumps blood. They will measure your heart's function and structure, and a heart-related marker called Hs-Troponin, at the beginning and after 52 weeks. To join, you need to be at least 18 years old and have congenital heart disease. The study aims to enroll 45 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study where participants are randomly assigned to receive either Entresto or a placebo. It plans to enroll 45 adults.
- What's involved
- You would take pills twice daily for 52 weeks. Your heart's function and structure, and a blood marker, will be measured at the start and after 52 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your heart's function and structure, and a blood marker, will be measured at the start and after 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
At a glance
Conditions
NCT06693674
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alexander Egbe · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Inclusion
Exclusion
What this trial measures
- Ventricular functionBaseline, Week 52
Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.
- Ventricular structureBaseline, Week 52
Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.
- Change from baseline in Hs-TroponinBaseline, Week 52
Hs-Troponin will be determined by blood specimen and will be measured in ng/L. A higher value indicates damage to the heart.
- Change from baseline in Galectin 3Baseline, Week 52
Galectin 3 will be determined by blood specimen and will be measure in ng/mL. A higher value indicates a higher severity of heart disease.
- Change from baseline in Cystatin CBaseline, Week 52
Cystatin C will be determined by blood specimen and measured in mg/L. A lower value reflects better kidney function.
- Change in baseline in Soluble ST-2 (sST-2)Baseline, Week 52
Soluble ST-2 (sST-2) will be determined by blood specimen and measured in ng/mL. A higher value indicates a higher severity of heart failure.
- Patient reported outcomesBaseline, Week 52
Patient reported outcomes will be determined by a quality-of-life questionnaire. A self-assessment survey to assess the extent to which heart failure (HF) affects the patient's activities of daily living and quality of life. The questionnaire is 12 questions and a lower score reflects more severe the limitations on daily life.