Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.
For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.
详细描述
The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.
The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration
- •Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
- •Meet baseline copeptin criteria for entry
- •Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)
排除标准
- •Current New York Heart Association Functional Class IV heart failure
- •Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
- •Presence of clinical contraindications to tolvaptan
- •Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
- •Cardiovascular surgical procedure within the past 4 weeks
- •CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
- •History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
- •Chronic uncontrolled diabetes mellitus as determined by the investigator.
- •Supine systolic arterial blood pressure < 90 mmHg at screening
- •Serum creatinine > 3.5 mg/dL at screening
- •Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening
- •Subjects currently treated with hemofiltration or dialysis
- •j. Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems
研究组 & 干预措施
Tolvaptan
Single arm study
干预措施: tolvaptan (Drug)
结局指标
主要结局
Body Weight
时间窗: Change over 24 hours
Change in body weight from baseline to 24 hours after tolvaptan administration
Urine Output
时间窗: 24 hours
Total urine output for 24 hours following tolvaptan administration
次要结局
未报告次要终点
研究者
Kirkwood Adams
Associate Professor of Medicine and Radiology
University of North Carolina, Chapel Hill