University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project (Manifold-HF)

University of Michigan

Status: Terminated

Conditions: Heart Failure

Treatments: Other: Flexible Diuretic Regimen; Device: Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02344342

HUM00091053

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days.
2. 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.
3. Patients must have an assessment of left ventricular function within the previous 2 years.
4. 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Health Buddy Web Management system

Experimental group

Description:

Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.

Treatment:

Device: Telemonitoring

Other: Flexible Diuretic Regimen

Flexible Diuretic Regimen

Experimental group

Description:

Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.

Treatment:

Device: Telemonitoring

Other: Flexible Diuretic Regimen