Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of Days Hospitalized or Dead in the 180 Day Follow up Period
研究概览
简要总结
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS).
详细描述
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The first intervention consists of the use of a home monitoring tool utilizing a tablet interface. The device facilitates collection of heart failure patient self-care information, including weight, blood pressure, heart rate and heart failure symptoms. This information is collected and stored on a secured server provided by the vendor, and can be viewed by the physician and nursing team. The second intervention is a flexible diuretic regimen strategy. This intervention will be applied in an independent randomized fashion. The flexible regimen will be prescribed by the patient's physician. The two interventions will be applied to heart failure patients treated at the University of Michigan. A total of 400 patients will be enrolled into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days.
- •Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment.
- •Patients must have an assessment of left ventricular function within the previous 2 years.
- •Patients must have LVEF ≤ 40%, or LVEF >40 with evidence of left atrial enlargement (LA dimension > 40 mm), BNP > 200 ng/ml or PCW > 18 mmHg.
排除标准
- •Prisoners
- •Residents of long term nursing facilities
- •Enrollment into a hospice program
- •Receiving dialysis
- •Patients with dementia
- •Patients with dGFR less than 20ml/min.
- •Patients being worked up for heart surgery.
- •Patients being worked up for heart transplant.
- •Patients being evaluated for revascularization.
- •Patients being evaluated for heart valve intervention.
- •Patients with primary pulmonary hypertension.
结局指标
主要结局
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
时间窗: 180 days (6 months)
This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.
次要结局
- Self Care for Heart Failure Index Score(180 day follow up)
- Minnesota Living With Heart Failure Questionnaire(180 day follow up)
- Days to Hospitalization or Death (if it Occurs Within 180 Days)(180 days)
研究者
Todd M Koelling, MD
Professor of Internal Medicine, Director of Heart Failure Program
University of Michigan