Effect of Sacubitril-Valsartan on Cardiac Structure and Function

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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.

1. First posted18 Nov 2024
2. Study start3 Feb 2025
3. Primary completionAug 2028 (estimated)
4. 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.