Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Ventricular function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital Heart Disease Diagnosis
- •Age 18 or Older
排除标准
- •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
- •Sparsentan
- •ACE inhibitor
研究组 & 干预措施
Entresto
干预措施: Entresto Pill (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Ventricular function
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic