University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project

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.

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 revasuculariztion.

- Patients being evaluated for heart valve intervention.

- Patients with primary pulmonary hypertension.