Effect of Sacubitril-Valsartan on Cardiac Structure and Function
NCT ID: NCT06693674
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
45 participants
INTERVENTIONAL
2025-02-03
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Entresto
Entresto Pill
Patients will take a 24/26 mg dose orally, twice daily, for weeks 1 and 2, 49/51 mg orally, twice daily, for weeks 3 and 4, and 97/103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).
Placebo
Placebo
Patients taking placebo tablets will take 1 tablet orally, twice daily
Interventions
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Entresto Pill
Patients will take a 24/26 mg dose orally, twice daily, for weeks 1 and 2, 49/51 mg orally, twice daily, for weeks 3 and 4, and 97/103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).
Placebo
Patients taking placebo tablets will take 1 tablet orally, twice daily
Eligibility Criteria
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Inclusion Criteria
* Age 18 or Older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Alexander C. Egbe
Principal Investigator
Principal Investigators
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Alexander Egbe
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-009099
Identifier Type: -
Identifier Source: org_study_id
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