NCT06099158 Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
| NCT ID | NCT06099158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tor Biering-Sørensen |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,428 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,428 participants in total. It began in 2024-05-31 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization 2. Age ≥18 years 3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored" Exclusion Criteria: There are no specific exclusion criteria for the trial.
Contact & Investigator
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
Frequently Asked Questions
Who can join the NCT06099158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06099158 currently recruiting?
Yes, NCT06099158 is actively recruiting participants. Contact the research team at niklas.dyrby.johansen@regionh.dk for enrollment information.
Where is the NCT06099158 trial being conducted?
This trial is being conducted at Hellerup, Denmark.
Who is sponsoring the NCT06099158 clinical trial?
NCT06099158 is sponsored by Tor Biering-Sørensen. The principal investigator is Tor Biering-Sørensen, MD, MSc, MPH, PhD at Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte. The trial plans to enroll 1,428 participants.
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