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Effect of Sacubitril-Valsartan on Cardiac Structure and Function

RECRUITINGPhase 3Sponsored by Mayo Clinic
Actively Recruiting
PhasePhase 3
SponsorMayo Clinic
Started2025-02-03
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06693674

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Congenital Heart DiseaseHeart Disease

Locations1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amanda Wozniak507-266-1976Wozniak.Amanda@mayo.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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