Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients

NCT07816458 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Alert-HF
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF). The main questions the trial aims to answer are: Does a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits? Researchers will compare these two groups to a standard care group to see which monitoring approach works best. Participants will: Answer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group. Use a handheld device to take weekly heart readings at home, if they are in the second group. Follow standard care from their regular doctor without any extra devices, if they are in the third group.

Conditions

Heart Failure

Keywords

Heart Failure; Implantable loop recorder (ILR); Portable ECG; Atrial fibrillation; Care consumption

Outcome Measures

Primary Outcomes (1)

• Number of unplanned cardiac care utilization

  Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare/day case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.

  18 months

Secondary Outcomes (7)

• Number of planned cardiac care utilization

  18 months

• Time to first diagnosis of AF

  18 months

• The number of participants diagnosed with AF

  18 months

• Pharmaceutical and/or CIED implantation management changes

  18 months

• Number of overall arrhythmia diagnosis

  18 months

Study Arms (3)

Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder

ACTIVE COMPARATOR

Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR)

Device: Implantable loop recorder

Arm 2: Patient-driven portable ECG monitoring

ACTIVE COMPARATOR

Patient-driven portable ECG monitoring

Device: Patient-driven portable ECG monitoring

Arm 3: Usual Care

ACTIVE COMPARATOR

All patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization.

Other: Usual Care

Interventions

Implantable loop recorder DEVICE

Hospital-driven continuous monitoring with an implantable loop recorder

Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder

Patient-driven portable ECG monitoring DEVICE

Patient-driven portable ECG monitoring

Arm 2: Patient-driven portable ECG monitoring

Usual Care OTHER

Usual care

Arm 3: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.

You may not qualify if:

• Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.
• Admission to hospices or palliative care
• Inability to communicate in Dutch or English.
• Participant is under age of 18 years old
• Participant is pregnant
• Mental disorders that, according to the treating physician, make participation unsafe

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Related Publications (7)

• Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.

  PMID: 26746177 BACKGROUND

• Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.

  PMID: 35902161 BACKGROUND

• Kober L, Adamo M, Ruwald AC, Tomasoni D, Anderson LJ, Andersson C, Brugts JJ, Chioncel O, Donal E, Ferdinandy P, Jhund PS, Leyva F, Lorusso R, Madigan M, Mullens W, Paolillo S, Ryan N, Simpson M, Thiele H, Thune JJ, Van Craenenbroeck EM, Van Laake LW, Verbakel M; ESC Guidelines Advisory Group. 2026 ESC Guidelines for the management of heart failure. Eur Heart J. 2026 Aug 28:ehag100. doi: 10.1093/eurheartj/ehag100. Online ahead of print. No abstract available.

  PMID: 42661420 BACKGROUND

• Baez-Ferrer N, Rodriguez-Cabrera CM, Parra-Esquivel PC, Burillo-Putze G, Dominguez-Rodriguez A. Prognostic Impact of Hospital Discharge After Heart Failure Admission Without Structured Heart Failure Follow-Up. J Clin Med. 2024 Dec 13;13(24):7589. doi: 10.3390/jcm13247589.

  PMID: 39768511 BACKGROUND

• Kwok CS, Seferovic PM, Van Spall HG, Helliwell T, Clarson L, Lawson C, Kontopantelis E, Patwala A, Duckett S, Fung E, Mallen CD, Mamas MA. Early Unplanned Readmissions After Admission to Hospital With Heart Failure. Am J Cardiol. 2019 Sep 1;124(5):736-745. doi: 10.1016/j.amjcard.2019.05.053. Epub 2019 Jun 6.

  PMID: 31300202 BACKGROUND

• Jansen C, Otterspoor LC, van Pol PEJ, IJff GC, Sinkeler SJ, van den Heuvel M, Jansen MEP, Scholten M, van Zutphen K, Verstappen CCAG, Hermanides N, Joosen IA, Heinen S, Valk JG, Vollenbroek-Hutten MMR, Schuuring MJ, van Hout GPJ. Structuring telemonitoring in heart failure care in The Netherlands: design and operational protocol of a nationwide initiative. Eur Heart J Digit Health. 2025 Nov 5;7(2):ztaf130. doi: 10.1093/ehjdh/ztaf130. eCollection 2026 Mar.

  PMID: 41624560 BACKGROUND

• Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.

  PMID: 35150240 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Schuuring, MD PhD

CONTACT

0031534872000; mark.schuuring@utwente.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)