Heart Failure, CongestiveMANAGE-HFNCT03237858

Multiple Cardiac Sensors for the Management of Heart Failure

A study testing HeartLogic ON and HeartLogic OFF in people with Heart Failure, Congestive, run by Boston Scientific Corporation at 30 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Congestive
What is being tested?: HeartLogic ON and HeartLogic OFF
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 30 sitesin 3 countries
Study dates: 30 Aug 2017to 21 Jul 2020
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

Subject is age 18 or above, or of legal age to give informed consent
Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
Remotely monitored by LATITUDE 5.0 (or future versions)
Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
Meet at least one of the three following conditions:

Show all 9Show fewer

At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment

Who cannot join

The subject is unable to sign or refuses to sign the patient informed consent
Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
The subject is implanted with unipolar right atrial or right ventricular leads
Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
Subject is pregnant or planning to become pregnant during the study
Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)

Show all 11Show fewer

Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
A life expectancy of less than 12 months per clinician discretion
APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

United States27 sites

Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
Southeast Texas Clinical Research Center
Beaumont, Texas, 77702
Medical University of South Carolina
Charleston, South Carolina, 29425
Lindner Center for Research and Education at Christ Hosp
Cincinnati, Ohio, 45219
Bethesda North Hospital
Cincinnati, Ohio, 45220
Centra Care Heart and Vascular Center
Cold Spring, Minnesota, 56320
Duke University Medical Center
Durham, North Carolina, 27705
Parkview Hospital, Inc.
Fort Wayne, Indiana, 46805
Stern Cardiovascular
Germantown, Tennessee, 38138
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Heart Center Research, LLC
Huntsville, Alabama, 35801
Community Health Network
Indianapolis, Indiana, 46250
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401
University of Southern California Hospital
Los Angeles, California, 90033
Catholic Medical Center
Manchester, New Hampshire, 03102
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Cardiovascular Consultants
Oakland, California, 94609
Rex Hospital
Raleigh, North Carolina, 27607
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
United Heart and Vascular
Saint Paul, Minnesota, 55102
Sharp Memorial Hospital
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94143
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71105
PeaceHealth Sacred Heart Medical Center
Springfield, Oregon, 97477
Montefiore Medical Center
The Bronx, New York, 10467
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067

Other trials in United States

France2 sites

L'Hôpital privé du Confluent
Nantes, 44277
CHU Pontchaillou
Rennes, 35033

Other trials in France

Germany1 site

Universitätsklinikum Würzburg AöR
Würzburg, 97080

Other trials in Germany

About this study

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Read the detailed description

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.

Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.

Conditions: Heart Failure, Congestive
Being tested: HeartLogic ON, HeartLogic OFF
Keywords: heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring
Medical subject headings: Heart Failure

What participants receive

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

HeartLogic ONDevice
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
HeartLogic OFFDevice
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON

Study groups in NCT03237858
Study group	Role	What they receive
HeartLogic ON	Active comparator	ICD and CRT-D devices with HeartLogic alerts turned ON Receives: Device: HeartLogic ON
HeartLogic OFF	Placebo comparator	ICD and CRT-D devices with HeartLogic alerts turned OFF Receives: Device: HeartLogic OFF

What is being measured

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

Manage-HF Phase I
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.
Measured: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit

Timeline

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

30 Aug 201721 Jul 2020

First posted3 Aug 2017
Study start30 Aug 2017
Primary completion21 Jul 2020
Study completion21 Jul 2020

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03237858
Sponsor's protocol ID: 92125179
Acronym: MANAGE-HF
Status last verified: Nov 2023
First submitted: 20 Jul 2017
Last updated: 27 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.
PubMed 35460884
Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.
PubMed 35129007

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, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Cardiac Sensors for the Management of Heart Failure
ClinicalTrials.gov ID: NCT03237858
Acronym / sponsor ID: MANAGE-HF / 92125179
Conditions: Heart Failure, Congestive
Keywords: heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 30 Aug 2017 (actual)
Primary completion: 21 Jul 2020 (actual)
Study completion: 21 Jul 2020 (actual)
First posted: 3 Aug 2017 (actual)
Results: Posted 27 Mar 2024

Clinical summary

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

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Detailed description

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HeartLogic ON	Active comparator	Device: HeartLogic ONICD and CRT-D devices with HeartLogic alerts turned ON
HeartLogic OFF	Placebo comparator	Device: HeartLogic OFFICD and CRT-D devices with HeartLogic alerts turned OFF

Who may qualify

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

Key inclusion criteria (9 listed)

Subject is age 18 or above, or of legal age to give informed consent
Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
Remotely monitored by LATITUDE 5.0 (or future versions)
Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.

Key exclusion criteria (11 listed)

The subject is unable to sign or refuses to sign the patient informed consent
Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
The subject is implanted with unipolar right atrial or right ventricular leads
Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
Subject is pregnant or planning to become pregnant during the study

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
HeartLogic ONRemote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF	Device	HeartLogic ON
HeartLogic OFFRemote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON	Device	HeartLogic OFF

Primary outcome

Manage-HF Phase I
Time frame: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit
Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MANAGE-HF Phase I	200	144

Primary outcome: Manage-HF Phase I

Time frame: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit. Count of participants. Unit: Participants

Measure	MANAGE-HF Phase I n = 191
Value	191

Population analysed: Manage-HF Phase II was not started, the trial was closed after phase I

Adverse events

Time frame: Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MANAGE-HF Phase I	100 of 200 (50%)	104 of 200 (52%)	19 of 200

Limitations and caveats (from the sponsor): Patients that were included in Phase I of MANAGE-HF were required to meet inclusion and exclusion criteria. This included evidence of worsened heart failure prior to enrollment, patients with severe kidney impairment or short life expectancy were excluded. Thus, the results are limited to the population that was studied. Furthermore, the small sample size and lack of a control group severely limits the interpretation of the results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35460884Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.
Derived from this study: PubMed 35129007Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.
Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart FailureLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Heart Failure, Congestive

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.

Adrian Hernandez, MD principal investigator

Duke University

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HeartLogic ON and HeartLogic OFF in people with Heart Failure, Congestive, run by Boston Scientific Corporation at 30 sites in 3 countries.

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 9 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: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, France, Germany. 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. Some participants in this study may receive a placebo. 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 27 Mar 2024). 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?

Manage-HF Phase I (time frame: Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit). 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 NCT03237858, which also lists 2 linked publications.

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 27 Mar 2024.