Congenital Heart DiseasePhase 3NCT06693674
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
A Phase 3 study testing Entresto Pill in people with Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Entresto Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Congenital Heart Disease Diagnosis
- Age 18 or Older
Who cannot join
- 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.
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- Drug Therapies
- Amifostine
- Droperidol
- Dantrolene
- CYP3A4 Inhibitors
- Obinutuzumab
- Aliskiren
- Lithium
- Sparsentan
- ACE inhibitor
- ARB
- ARNI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amanda Wozniak, 507-266-1976, Wozniak.Amanda@mayo.edu
Alexander C Egbe
About this study
Official title: Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
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.
- Conditions
- Congenital Heart Disease
- Being tested
- Entresto Pill, Placebo
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entresto PillDrug
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).
PlaceboOther
Patients taking placebo tablets will take 1 tablet orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Entresto | Experimental | Not described Receives: Drug: Entresto Pill |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular function
Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.
Measured: Baseline, Week 52
Ventricular structure
Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.
Measured: Baseline, Week 52
Change from baseline in Hs-Troponin
Hs-Troponin will be determined by blood specimen and will be measured in ng/L. A higher value indicates damage to the heart.
Measured: Baseline, Week 52
Change from baseline in Galectin 3
Galectin 3 will be determined by blood specimen and will be measure in ng/mL. A higher value indicates a higher severity of heart disease.
Measured: Baseline, Week 52
Change from baseline in Cystatin C
Cystatin C will be determined by blood specimen and measured in mg/L. A lower value reflects better kidney function.
Measured: Baseline, Week 52
Change in baseline in Soluble ST-2 (sST-2)
Soluble ST-2 (sST-2) will be determined by blood specimen and measured in ng/mL. A higher value indicates a higher severity of heart failure.
Measured: Baseline, Week 52
Patient reported outcomes
Patient reported outcomes will be determined by a quality-of-life questionnaire. A self-assessment survey to assess the extent to which heart failure (HF) affects the patient's activities of daily living and quality of life. The questionnaire is 12 questions and a lower score reflects more severe the limitations on daily life.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start3 Feb 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexander C. Egbe, Mayo Clinic
- Investigators
- Alexander Egbe, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693674
- Sponsor's protocol ID
- 24-009099
- Other IDs
- 5R01HL162830-02
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06693674
- Acronym / sponsor ID
- 24-009099
- Conditions
- Congenital Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entresto | Experimental | Drug: Entresto Pill |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Congenital Heart Disease Diagnosis
- Age 18 or Older
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entresto PillPatients 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). | Drug | Entresto |
| PlaceboPatients taking placebo tablets will take 1 tablet orally, twice daily | Other | Placebo |
Primary outcome
Ventricular function
Time frame: Baseline, Week 52
Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.
Ventricular structure
Time frame: Baseline, Week 52
Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.
Change from baseline in Hs-Troponin
Time frame: Baseline, Week 52
Hs-Troponin will be determined by blood specimen and will be measured in ng/L. A higher value indicates damage to the heart.
Change from baseline in Galectin 3
Time frame: Baseline, Week 52
Galectin 3 will be determined by blood specimen and will be measure in ng/mL. A higher value indicates a higher severity of heart disease.
Change from baseline in Cystatin C
Time frame: Baseline, Week 52
Cystatin C will be determined by blood specimen and measured in mg/L. A lower value reflects better kidney function.
Change in baseline in Soluble ST-2 (sST-2)
Time frame: Baseline, Week 52
Soluble ST-2 (sST-2) will be determined by blood specimen and measured in ng/mL. A higher value indicates a higher severity of heart failure.
Patient reported outcomes
Time frame: Baseline, Week 52
Patient reported outcomes will be determined by a quality-of-life questionnaire. A self-assessment survey to assess the extent to which heart failure (HF) affects the patient's activities of daily living and quality of life. The questionnaire is 12 questions and a lower score reflects more severe the limitations on daily life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Egbe principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entresto Pill in people with Congenital Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Wozniak (507-266-1976, Wozniak.Amanda@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular function (time frame: Baseline, Week 52). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.