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

Heart Failure Clinical Trial

— Manifold-HF  

Official title:

Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02344342
• Other study ID #: HUM00091053
• Status: Terminated
• Phase: N/A
• First received: January 16, 2015
• Last updated: June 7, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.

Other:
• Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days hospitalized and/or dead in the 180 day follow up period		180 days (6 months)	No
Secondary	Time to death or all cause hospitalization		180 days (6 months)	No
Secondary	Time to death or heart failure hospitalization		180 days (6 months)	No
Secondary	Specific Activity Scale		Baseline and 180 day follow up	No
Secondary	Self Care for Heart Failure Index score		Baseline and 180 day follow up	No
Secondary	Minnesota Living with Heart Failure Questionnaire		Baseline and 180 day follow up	No
Secondary	Interaction between cognition as measured by the Hopkins Verbal Learning Test and the home monitoring intervention		180 days	No
Secondary	Interaction between cognition as measured by the Hopkins Verbal Learning Test and the flexible diuretic intervention		180 days	No