NCT06693674 · Mayo Clinic
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
What this study is about
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) randomly assigned to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.
View original scientific description
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.
Interventions
DRUG
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).
OTHER
Placebo
Patients taking placebo tablets will take 1 tablet orally, twice daily
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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,
- Drug Therapies
- CYP3A4 Inhibitors
- Obinutuzumab
- ACE inhibitor
Where
- Rochester, Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations