Heart FailureManifold-HFNCT02344342

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

A study testing Telemonitoring and Flexible Diuretic Regimen in people with Heart Failure, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Telemonitoring and Flexible Diuretic Regimen
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Prisoners
Residents of long term nursing facilities
Enrollment into a hospice program
Receiving dialysis
Patients with dementia
Patients with dGFR less than 20ml/min.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Health System
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

Read the 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.

Conditions: Heart Failure
Being tested: Telemonitoring, Flexible Diuretic Regimen
Keywords: telemonitoring
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelemonitoringDevice
Also called Bosch Health Buddy Web Management System
The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
Flexible Diuretic RegimenOther
Patients will have a prescribed diuretic regimen specified by specific weight ranges.

Study groups in NCT02344342
Study group	Role	What they receive
Health Buddy Web Management system	Experimental	Patients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system. Receives: Device: Telemonitoring; Other: Flexible Diuretic Regimen
Flexible Diuretic Regimen	Experimental	Patients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges. Receives: Device: Telemonitoring; Other: Flexible Diuretic Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Days Hospitalized or Dead in the 180 Day Follow up Period
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.
Measured: 180 days (6 months)

Secondary outcomes (3)

Self Care for Heart Failure Index Score
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.
Measured: 180 day follow up
Minnesota Living With Heart Failure Questionnaire
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),
Measured: 180 day follow up
Days to Hospitalization or Death (if it Occurs Within 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.
Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Dec 2015

First posted22 Jan 2015 (estimated)
Study startFeb 2015
Primary completionSep 2015
Study completionDec 2015

Why it stopped: The industry sponsor has discontinued the product under evaluation in the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02344342
Sponsor's protocol ID: HUM00091053
Acronym: Manifold-HF
Status last verified: Mar 2017
First submitted: 16 Jan 2015
Last updated: 2 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Michigan Advanced Heart Failure TelemoNItoring and FLexible Diuretic Trial - MANIFOLD-HF
ClinicalTrials.gov ID: NCT02344342
Acronym / sponsor ID: Manifold-HF / HUM00091053
Conditions: Heart Failure
Keywords: telemonitoring
Study type: Interventional
Recruitment status: TerminatedReason stopped: The industry sponsor has discontinued the product under evaluation in the study.
Enrolment: 51 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Feb 2015
Primary completion: Sep 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 22 Jan 2015 (estimated)
Results: Posted 2 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Health Buddy Web Management system	Experimental	Device: Telemonitoring, Other: Flexible Diuretic RegimenPatients randomized to the telemonitoring intervention will be assigned to use the Bosch Health Buddy Web management system.
Flexible Diuretic Regimen	Experimental	Device: Telemonitoring, Other: Flexible Diuretic RegimenPatients randomized into the Flexible Diuretic Regimen intervention will have a diuretic regimen specified by specific weight ranges.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

Prisoners
Residents of long term nursing facilities
Enrollment into a hospice program
Receiving dialysis
Patients with dementia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelemonitoringAlso: Bosch Health Buddy Web Management SystemThe Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.	Device	Flexible Diuretic Regimen, Health Buddy Web Management system
Flexible Diuretic RegimenPatients will have a prescribed diuretic regimen specified by specific weight ranges.	Other	Flexible Diuretic Regimen, Health Buddy Web Management system

Primary outcome

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.

3 secondary outcomes

Self Care for Heart Failure Index Score
Time frame: 180 day follow up
Minnesota Living With Heart Failure Questionnaire
Time frame: 180 day follow up
Days to Hospitalization or Death (if it Occurs Within 180 Days)
Time frame: 180 days

Results and safety

Results posted to the registry on 2 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Health Buddy Yes and Flexible Diuretic Yes	13	2
Health Buddy Yes and Flexible Diuretic Regimen No	11	2
Health Buddy No and Flexible Diuretic Yes	14	0
Health Buddy No and Flexible Diuretic No	13	3

Primary outcome: Number of Days Hospitalized or Dead in the 180 Day Follow up Period

Time frame: 180 days (6 months). Number. Unit: Days

Measure	Health Buddy Yes and Flexible Diuretic Yes n = 2	Health Buddy Yes and Flexible Diuretic No n = 2	Health Buddy No and Flexible Diuretic Yes n = 0	Health Buddy No and Flexible Diuretic No n = 3
Value	5	23	–	0

Population analysed: The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 days (or 6 months) from discharge date or from the day patient started using the intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Health Buddy Web YES/Flexible Diuretic YES	5 of 13 (38.5%)	0 of 13 (0%)	1 of 13
Health Buddy Web YES /Flexible Diuretic NO	4 of 11 (36.4%)	0 of 11 (0%)	1 of 11
Health Buddy Web NO/Flexible Diuretic YES	7 of 14 (50%)	0 of 14 (0%)	2 of 14
Health Buddy Web NO /Flexible Diuretic NO	6 of 13 (46.2%)	0 of 13 (0%)	1 of 13

Limitations and caveats (from the sponsor): Early termination leading to a small number of subjects analyzed. We have enrolled a total of 51 patients when our target was to enroll 400 patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd M Koelling, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring and Flexible Diuretic Regimen in people with Heart Failure, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Days Hospitalized or Dead in the 180 Day Follow up Period (time frame: 180 days (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02344342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.