University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project
NCT ID: NCT02344342
Last Updated: 2017-05-02
Study Results
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View full resultsBasic Information
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TERMINATED
NA
51 participants
INTERVENTIONAL
2015-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Health Buddy Web Management system
Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.
Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Flexible Diuretic Regimen
Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.
Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Interventions
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Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Todd M Koelling, MD
Professor of Internal Medicine, Director of Heart Failure Program
Principal Investigators
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Todd M Koelling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Health System
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00091053
Identifier Type: -
Identifier Source: org_study_id
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