The Gender-Based Differences in the Outcome of Treatment by Aldosterone Antagonists in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Switching from one mineralocorticoid receptor antagonist to another
研究概览
简要总结
Heart failure (HF) is a major healthcare problem. In patients with Heart Failure with Reduced Ejection Fraction (HFrEF), aldosterone antagonists reduce mortality and hospitalization rate. Gender-related differences have been described in the regulation of renin angiotensin aldosterone system (RAAS), which is at the core of the pathophysiology of HF. Regarding gender-related differences in the use of MRAs, less is known about the effects of androgens on RAAS.
In this single-center prospective cohort, a total of 100 adult (≥ 18 years) ambulatory patients of both sexes with the diagnosis of HF with HFrEF (LVEF≤ 40%) and NYHA class II-IV under optimized medical therapy started an aldosterone antagonist are enrolled and followed-up for 6 months. Patients are categorized according to their apparent sexual gender into two groups: the male group and the female group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of heart failure with reduced ejection fraction HFrEF (LVEF≤ 40%) and New York Heart Association (NYHA) class II-IV under optimized medical therapy who are presented to the outpatient clinic and started an aldosterone antagonist at the time of enrollment.
排除标准
- •Pregnancy or breast-feeding.
- •Serum creatinine > 2.5 mg/dL (221 μmol/L) in males and > 2 mg/dL (177 μmol/L) in women (or estimated glomerular filtration rate eGFR ≤ 30 mL/minute/1.73 m2).
- •Hyperkalemia (serum potassium level > 5 mEq/L).
- •Renal transplant.
- •Concomitant administration of strong CYP3A inhibitors.
- •Concomitant administration of potassium supplements or potassium-sparing diuretics.
- •Disorders of adrenal glands (Addison disease).
- •Patients who used mineralocorticoid receptor antagonists in the last 2 weeks before enrollment.
- •Patients with a history of mineralocorticoid receptor antagonists allergy or intolerance.
研究组 & 干预措施
The Female Group
Patients with an apparent gender of female.
干预措施: Potassium sparing diuretic (Drug)
The Male Group
Patients with an apparent gender of male.
干预措施: Potassium sparing diuretic (Drug)
结局指标
主要结局
Switching from one mineralocorticoid receptor antagonist to another
时间窗: 6 months after enrollment
Changing the mineralocorticoid receptor antagonist used
Heart failure hospitalization
时间窗: 6 months after enrollment
The incidence of Hospitalization due to heart failure
Acute myocardial infarction
时间窗: 6 months after enrollment
The incidence of acute myocardial infarction
Percentage of patients who discontinued mineralocorticoid receptor antagonist
时间窗: 6 months after enrollment
Discontinuation of mineralocorticoid receptor antagonist
Adverse effects
时间窗: 6 months after enrollment
The occurrence of Hyperkalemia, hypochloremic alkalosis, dehydration, or MRA adverse effects
Acute Kidney Injury
时间窗: 6 months after enrollment
The incidence of acute kidney injury
次要结局
- All-cause hospitalization rate(6 months after enrollment)
- All-cause mortality rate(6 months after enrollment)