Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University of Michigan
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Number of Days Hospitalized or Dead in the 180 Day Follow up Period
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Todd M Koelling, MD
Professor of Internal Medicine, Director of Heart Failure Program
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Number of Days Hospitalized or Dead in the 180 Day Follow up Period
Time Frame: 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.
Secondary Outcomes
- 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)