High-dose Aldosterone Antagonist for Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- symptoms relief
研究概览
简要总结
Primary Aims
- Evaluate the safety of high-dose spironolactone in combination of patiromer in acute decompensated heart failure patients.
- Evaluate the efficacy of high-dose spironolactone in combination of patiromer in causing volume loss and symptom relief in patients with ADHF treated with high-dose spironolactone.
Secondary Aims
1: Evaluate the effect of high-dose spironolactone on urinary sodium excretion and renal function.
详细描述
Step-by-Step Methods:
Pre-screening: Patients meeting the inclusion and exclusion criteria will be approached to participate in the study. Informed consent will be taken at this time. These patients will receive intravenous loop diuretic per the discretion of treating physician and will be closely followed for weight loss and symptoms relief.
Screening: The patients who don't respond as measured by symptoms relief or <0.5 kg weight loss/day
- Despite furosemide ≥ 160 mg IV total daily dose or equivalent dose of torsemide or bumetanide. (1 mg bumetanide = 10 mg torsemide = 20 mg furosemide). OR
- After 48 hours irrespective of diuretic dose.
will be considered for the study intervention. Patients who have not participated in the pre-screening phase and do not respond adequately to furosemide >160 mg iv daily dose will directly be enrolled into active intervention part of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •More than18 years old
- •Hospitalized with history of chronic heart failure and at least one symptom (dyspnea, orthopnea or edema) and one sign (rales, peripheral edema, ascites, or radiographic pulmonary edema or pleural effusion)
- •Use of loop diuretics
- •Women of child bearing age with negative urine pregnancy test
排除标准
- •Acute coronary syndrome
- •Patients with a baseline eGFR < 30 ml/min by MDRD equation
- •Baseline potassium concentration ≥ 5.5 mEq/L
- •Requirement for intravenous vasodilators or inotropic agents
- •Systemic infection
- •Patients with concomitant end-stage liver disease
- •Hemodynamically significant uncorrected valvular disease
- •Patients with pulmonary embolism
- •Patients with high output heart failure
- •Pregnant patients
研究组 & 干预措施
Intervention
Spironolactone and patiromer
干预措施: Spironolactone and patiromer (Drug)
结局指标
主要结局
symptoms relief
时间窗: up to 10 days
Improved swelling and shortness of breath suggestive of volume loss
Weight loss
时间窗: up to 10 days
Improved swelling and shortness of breath suggestive of volume loss
次要结局
- Hypo- or hyperkalemia(up to 10 days)
- Urinary FENa and Urinary Na/K ratio(Up to 10 days)