Effect of Sacubitril-Valsartan on Cardiac Structure and Function

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later Dec 2026 → Aug 2028
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Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 2026 to Aug 2028
    • Eligibility criteria expanded, about 12 words
  2. Notable Primary endpoints revised (7)
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 5 words
    v5
  3. Minor Start date changed from estimate of Feb 2025 to Feb 3, 2025
    • Site contact updated
    v4
  4. Minor Start date: Jan 2025 to Feb 2025
    • Eligibility criteria shortened, about 2 words
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2024 to Jan 2025
    • Site details revised
    v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,024 trials monitored
See 128 trials at risk
8,814 trials monitored
See 428 trials at risk
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.
Trial Details
NCT Number NCT06693674
Lead Sponsor Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Congenital Heart Disease
Related terms Heart Defects, Congenital
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov