NCT06693674 Effect of Sacubitril-Valsartan on Cardiac Structure and Function
| NCT ID | NCT06693674 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mayo Clinic |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 45 participants in total. It began in 2025-02-03 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.
Eligibility Criteria
Inclusion Criteria: * Congenital Heart Disease Diagnosis * Age 18 or Older Exclusion Criteria: * Stage IV chronic kidney disease defined as creatinine clearance \<30 ml/min * Hyperkalemia defined as serum potassium \>5.2 mmol/l, * Hypotension defined as systolic blood pressure \<100 mmHg, * History of angioedema related to previous ACE or ARB therapy * Patients diagnosed with diabetes using Aliskiren, * Pregnancy. * Drug Therapies * Amifostine * Droperidol * Dantrolene * CYP3A4 Inhibitors * Obinutuzumab * Aliskiren * Lithium * Sparsentan * ACE inhibitor * ARB * ARNI
Contact & Investigator
Alexander Egbe
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06693674 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06693674 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 45 participants.
Is NCT06693674 currently recruiting?
Yes, NCT06693674 is actively recruiting participants. Contact the research team at Wozniak.Amanda@mayo.edu for enrollment information.
Where is the NCT06693674 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06693674 clinical trial?
NCT06693674 is sponsored by Mayo Clinic. The principal investigator is Alexander Egbe at Mayo Clinic. The trial plans to enroll 45 participants.