Last reviewed · How we verify
NCT06173089: REMOTE-HEART
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
trial testing Remote monitoring in Heart Failure in 800 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | Semmelweis University Heart and Vascular Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 30 January 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 August 2025 |
| Sites | 1 location across Hungary |
Drugs / interventions tested
- Remote monitoring
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Semmelweis University Heart and Vascular Center
Who can join
Adults 18 to 100, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events. The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class. By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated. Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06173089
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Semmelweis University Heart and Vascular Center trials
Trials by the same sponsor.
- NCT07434193 — Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergo · NA · recruiting
- NCT07296965 — Oral Microbiome in Carotid Atherosclerosis · recruiting
- NCT06501313 — PhotobiomoduLation for pAtientS With Advanced hEart failuRe · NA · not yet recruiting
- NCT05838937 — The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients · not yet recruiting
- NCT04909190 — Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06173089 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Semmelweis University Heart and Vascular Center
- Last refreshed: 15 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06173089.
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