Clinical trial NCT02344342: University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project
Official title: Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: telemonitoring
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Days Hospitalized or Dead in the 180 Day Follow up Period
timeFrame: 180 days (6 months)
Secondary outcomes:
measure: Self Care for Heart Failure Index Score
timeFrame: 180 day follow up
measure: Minnesota Living With Heart Failure Questionnaire
timeFrame: 180 day follow up
measure: Days to Hospitalization or Death (if it Occurs Within 180 Days)
timeFrame: 180 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd M Koelling, MD
role: PRINCIPAL_INVESTIGATOR
References: