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Active, not recruiting Phase 4

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

NCT05637853 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 4
Started
2022-10-22
Last updated
2025-04-15

Condition(s) studied

Heart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

GDMT →

GDMT: Predifined fast uptitration of GDMT for HFrEF with support of home monitoring.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients diagnosed with HFrEF and without contraindications for either of the following drug classes: SGLT2i, BB, RAASi and MRA. Exclusion Criteria: * Estimated glomerular filtration rate (eGFR)\<45 ml/min Patients with HFrEF already on treatment with either BB or ACEi/ARNI/ARB and up titrated to \>50% of maximal recommended dose. Patients who do not have access to a smartphone or internet connection at home. Patients not able to comprehend the technical aspects of home monitoring or unable to give informed consent.

Primary outcome measure(s)

  • Safety and feasibility of fast telemonitored sequencing of heart failure medications in HFrEF patients — 180 days
    Incidence of treatment-emergent adverse events up to 180 days from start of sequencing.

Trial sites (1)

FacilityCityRegionStatus
Sahlgrenska University Hospital Gothenburg Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05637853 on ClinicalTrials.gov ↗ ← All trials in Sweden