Heart FailureDANLOGIC-HFNCT06099158
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
A study testing HeartLogic in people with Heart Failure, run by Tor Biering-Sørensen at 5 sites in Denmark.
Trial summary
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartLogic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,428 participants
- Where
- 5 sitesDenmark
- Study dates
- 31 May 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization
- Age ≥18 years
- Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"
Who cannot join
- There are no specific exclusion criteria for the trial.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Jens Cosedis Nielsen, MD, DMSc, PhD, +4578452039, jenniels@rm.dk
Brian Bridal Løgstrup, MD, DMSc, PhD, +4540142493, bbl@skejby.rm.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Lars Køber, DMSc, PhD, +4535458525, lars.koeber.01@regionh.dk
Niels Risum, MD, PhD, niels.risum.01@regionh.dk
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, 2900
Frederik Holme Fussing, MD, +4521547157, frederik.holme.fussing@regionh.dk
Lise Witten Davodian, MD, +4521639531, lise.witten.davodian@regionh.dk
- Recruiting
Odense University Hospital
Odense, 5000
Preman Kumarathurai, MD, PhD, +4520219670, preman.kumarathurai@rsyd.dk
Jens Brock Johansen, MD, PhD, jens.johansen@rsyd.dk
- Recruiting
Zealand University Hospital
Roskilde, 4000
Ketil Jørgen Haugan, MD, +4547326180, khau@regionsjaelland.dk
About this study
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
Read the detailed description
The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
- Conditions
- Heart Failure
- Being tested
- HeartLogic
- Keywords
- Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLogicOther
HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.
| Study group | Role | What they receive |
|---|---|---|
| HeartLogic-guided management | Experimental | HeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines. Receives: Other: HeartLogic |
| Standard care | No intervention | The control group will receive usual HF care in the Danish health system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of hospitalization for heart failure or all-cause death (first event)
Measured: 42 months
Secondary outcomes (4)
Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)
Measured: 42 months
Hospitalization for heart failure (first event)
Measured: 42 months
All-cause hospitalization
Measured: 42 months
All-cause mortality
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start31 May 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, MSc, MPH, PhD, Study chair, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099158
- Sponsor's protocol ID
- DANLOGIC-HF
- Acronym
- DANLOGIC-HF
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
- ClinicalTrials.gov ID
- NCT06099158
- Acronym / sponsor ID
- DANLOGIC-HF / DANLOGIC-HF
- Conditions
- Heart Failure
- Keywords
- Pragmatic, Heart disease, ICD, CRT-D, Pacemaker, Registry, HeartLogic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,428 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 31 May 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
Detailed description
The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartLogic-guided management | Experimental | Other: HeartLogicHeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines. |
| Standard care | No intervention | –The control group will receive usual HF care in the Danish health system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization
- Age ≥18 years
- Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for the trial.
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 |
|---|---|---|
| HeartLogicHeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts. | Other | HeartLogic-guided management |
Primary outcome
Composite endpoint of hospitalization for heart failure or all-cause death (first event)
Time frame: 42 months
4 secondary outcomes
Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)
Time frame: 42 months
Hospitalization for heart failure (first event)
Time frame: 42 months
All-cause hospitalization
Time frame: 42 months
All-cause mortality
Time frame: 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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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.
Tor Biering-Sørensen, MD, MSc, MPH, PhD study chair
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartLogic in people with Heart Failure, run by Tor Biering-Sørensen at 5 sites in Denmark.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik Holme Fussing, MD (+4521547157, frederik.holme.fussing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of hospitalization for heart failure or all-cause death (first event) (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.