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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL162830-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entresto | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entresto Pill | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Week 52 |
| Patient reported outcomes |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Wozniak | Contact | 507-266-1976 | Wozniak.Amanda@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Egbe | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| Placebo | Other | Patients taking placebo tablets will take 1 tablet orally, twice daily |
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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.
| Baseline, Week 52 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |