NCT06641921

Strategy TO Prevent Decompensated Heart Failure

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Seerlinq s. r. o. · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, multicenter, single-arm, open-label clinical trial (Strategy TO Prevent Decompensated Heart Failure) is to evaluate the 6month incidence of heart failure hospitalization (HFH) and all cause mortality in patients managed with haemodynamically guided treatment using the Seerlinq telemedical monitoring system.

Detailed description

Study participants will receive the Seerlinq telemedical monitoring system with appropriate training and will perform regular measurements as instructed. HF treatment will be haemodynamically-guided, with clinical decisions informed by trends in LVFP determined by Seerlinq. The primary treatment goal will be to lower elevated LVFP using diuretics, vasodilators, or neurohormonal agents. In addition to LVFP, treatment decisions will be supported by heart rate, patient perceived symptoms (fatigue and shortness of breath) and blood pressure values measured using a certified home blood pressure monitor, enabling more individualized titration of therapy based on a comprehensive haemodynamic profile. In cases where elevated LVFP persists despite treatment adjustments and consultation with a healthcare professional via telephone, or where there is evidence of non-response, patients will be promptly scheduled for an urgent in-person clinical evaluation to assess fluid status, comorbidities, and potential treatment barriers. Furthermore, the Seerlinq-guided approach will aim for the accelerated uptitration of guideline-directed medical therapy (GDMT) based on haemodynamic tolerance. Haemodynamically guided management will be conducted according to a prespecified protocol (Treatment Protocol) in line with current guidelines for management of chronic heart failure

Conditions

• Heart Failure
• Remote Monitoring

Interventions

Type	Name	Description
DEVICE	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. .

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2024-10-15
• Last updated: 2025-12-18

Locations

1 site across 1 country: Slovakia