Congenital Heart Disease
Conditions
Brief 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.
Interventions
DRUGEntresto 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).
OTHERPlacebo
Patients taking placebo tablets will take 1 tablet orally, twice daily
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular function | 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 | 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 | 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 | 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 | 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) | 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 | 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. |
Countries
United States
Contacts
Primary ContactAmanda Wozniak
Outcome results
None listed