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Telemonitored Fast Track Medical Sequencing for Heart Failure With Reduced Ejection Fraction

Study acronym: TELE-FASTER
StatusActive, Not Recruiting
PhasePhase 4
Started2022-10-22
View on ClinicalTrials.gov ↗

Amendment history

2025-04-10
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
PhaseNot specified→Phase 4
Primary completion dateestimated 2024-08-22→confirmed 2024-08-26
Completion date2024-10-22→2026-08-26
Enrollment targetestimated 200→confirmed 60
Interventionsnot stated→GDMT (Drug)
Secondary endpoints3 entries, revised
Proportion of patients reaching full doses or OMT of heart failure drugs with home -monitoring Proportion of patients capablestill of reachingon full dosestarget ofdosage heart failure drugs compared to standard of care. Proportion of patients still onor OMT in future follow-up Changes in levels of NTproBNP during home monitored sequencing
Study description+44 characters
[...] y. Study synopsis Primary aim: The primary aim is to assess the safetyeffectivness and safety/feasibility of fast telemonitored sequencing of heart failur [...] have previous experience of the home monitoring equipment. A controll group with HFrEF under standard of care will be retrospecively collected and matched with the intervention group for comparison. Objectives: i. Primary objective To study whethersafety and feasability of fast telemonitored sequencing in HFrEF patients is safe and feasible. ii. Secondary objectives To investigate whether titration to full target doses or OMT of all four cla [...] [...]
Study sitesdetails revised at 1 of 1 site
2022-11-25
minor
Original filing
Research hypothesis: Fast telemonitored medical sequencing in patients with heart failure with reduced ejection fraction (HFrEF) is safe and feasible. Background: Modern therapy for HFrEF offers a highly effective arsenal of drugs, devices and interventional therapies, yet mortality and morbidity remain high in the cohort. One major problem is that drug therapy introduction and up titration has been very hard to implement in a majority of HFrEF patients. Most previous telemonitoring studies have focused on the continuous monitoring of patients and the monitoring itself has been the main intervention. A potentially more effective way to use telemonitoring in heart failure patients may be to combine the technique with a medical intervention when the patients are most vulnerable to heart failure events. The best therapeutic window lies in the period after newly diagnosed heart failure or right after a recent hospitalization following worsened chronic HFrEF. Method: We aim to use telemonitoring for fast sequencing of heart failure drugs for patients with HFrEF.
Trial Details
NCT Number NCT05637853
Lead Sponsor Göteborg University
Conditions Heart Failure With Reduced Ejection Fraction
Enrollment 60 participants
Start Date 2022-10-22
Primary Completion 2024-08-26 (estimated)
Study Completion 2026-08-26 (estimated)
Updated on ClinicalTrials.gov 2025-04-15