University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project (Manifold-HF)

March 21, 2017 updated by: Todd M Koelling, MD, University of Michigan

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Buddy Web Management system
Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.
Device: Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Other Names:
  • Bosch Health Buddy Web Management System
Other: Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.
Experimental: Flexible Diuretic Regimen
Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.
Device: Telemonitoring
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Other Names:
  • Bosch Health Buddy Web Management System
Other: Flexible Diuretic Regimen
Patients will have a prescribed diuretic regimen specified by specific weight ranges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
180 days (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self Care for Heart Failure Index Score
Time Frame: 180 day follow up
The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly.
180 day follow up
Minnesota Living With Heart Failure Questionnaire
Time Frame: 180 day follow up
It provides a total score (range 0-105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life),
180 day follow up
Days to Hospitalization or Death (if it Occurs Within 180 Days)
Time Frame: 180 days
Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00091053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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