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Strategy TO Prevent Decompensated Heart Failure
Sponsor: Seerlinq s. r. o.
Summary
The goal of this prospective, multicenter, single-arm, open-label clinical trial (Strategy TO Prevent Decompensated Heart Failure) is to evaluate the 12-month incidence of heart failure hospitalization (HFH) and all cause mortality in patients managed with haemodynamically guided treatment using the Seerlinq telemedical monitoring system.
Official title: A Multi-centre, Prospective, Single-arm, Open-label Trial With a Prespecified Effectiveness Endpoint to Evaluate the Benefits of Haemodynamically Guided Treatment Using the Seerlinq HeartCore System in Heart-failure Patients.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2024-05-01
Completion Date
2026-05-01
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Seerlinq Telemedical Monitoring System
Participants will use the Seerlinq telemedical monitoring system and receive standardized remote training to perform regular photoplethysmography (PPG) measurements and symptom reporting. Heart failure management will be hemodynamically guided, with treatment decisions based primarily on trends in estimated left ventricular filling pressure (LVFP) derived from Seerlinq. The therapeutic goal is to reduce elevated LVFP through adjustment of diuretics, vasodilators, or neurohormonal agents. Additional parameters-including heart rate, patientreported fatigue and shortness of breath, and home blood pressure values-will support individualized therapy titration. If elevated LVFP persists despite remote treatment adjustments, patients will be scheduled for inperson clinical evaluation. Guidelinedirected medical therapy (GDMT) will be uptitrated according to hemodynamic tolerance following a prespecified treatment protocol aligned with current heart failure management guidelines. .
Locations (1)
Premedix Clinic
Bratislava, Nové Mesto, Slovakia