A Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide Over 12 Hours After Dosing in Patients With Heart Failure (EXTOR-HF)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Cumulative Na+ excretion over 6 hours
研究概览
简要总结
This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.
详细描述
The goal of this randomized double-blind crossover study is to assess whether extended release torsemide has a better efficacy than immediate release torsemide to induce renal sodium excretion after a salty lunch in patients with heart failure. The study will address if:
- the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a morning dose of extended release torsemide is different from the amounts after the immediate release torsemide.
- the amounts of excreted sodium in the urine during the 2- and 6-hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amounts after the immediate release torsemide.
- the amount of excreted sodium in the urine during the 24 hours' time period after a salty lunch, which will be consumed approximately 6 hours following a morning dose of extended release torsemide, is different from the amount after the immediate release torsemide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Man or woman over the age of 18 years.
- •Willing and able to sign the informed consent.
- •A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician or an experienced clinician to be stable over the one-month period prior to randomization.
- •Receiving oral furosemide (or equivalent doses of torsemide or bumetanide) for about 30 days prior to randomization.
- •No anticipated changes in HF medications during the study period.
- •Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period
排除标准
- •Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, at randomization and during the study.
- •Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
- •Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
- •Urinary incontinence or inability to empty bladder.
- •Uncontrolled diabetes mellitus or uncontrolled hypertension.
- •Estimated GFR < 30 ml/min/1.72m
- •History of flash pulmonary edema or amyloid cardiomyopathy.
- •Female patients who are breastfeeding.
研究组 & 干预措施
Extended release torsemide
Drug: Extended release torsemide 24 mg tablet. Subjects will receive oral dose of 24 mg extended release torsemide tablet and a placebo of 20 mg immediate release torsemide.
干预措施: torsemide (Drug)
Immediate release torsemide
Drug: Immediate release torsemide 20 mg tablet. Subjects will receive oral dose of 20 mg of immediate release torsemide and a placebo of 24 mg extended release torsemide.
干预措施: torsemide (Drug)
结局指标
主要结局
Cumulative Na+ excretion over 6 hours
时间窗: 6 hours after lunch
The primary outcome is the cumulative Na+ excretion over 6 hours after lunch.
次要结局
- Fluid and Na+ excretion over the 6 hours(6 hours after breakfast, 6 hours after lunch, and 24 hours])
- Creatinine clearance(While in the study (approximately 2 weeks))
- K+ excretion(While in the study (approximately 2 weeks))