Effect of Sacubitril-Valsartan on Cardiac Structure and Function

NCT ID: NCT06693674

Last Updated: 2025-10-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Entresto

Group Type EXPERIMENTAL

Entresto Pill

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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).

Intervention Type DRUG

Placebo

Patients taking placebo tablets will take 1 tablet orally, twice daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alexander C. Egbe

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Wozniak

Role: CONTACT

507-266-1976

Facility Contacts

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Amanda Wozniak

Role: primary

507-266-1976

Other Identifiers

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5R01HL162830-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-009099

Identifier Type: -

Identifier Source: org_study_id

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