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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.

NCT06641921•Seerlinq s. r. o.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged ≥ 18 years.
•2. Able to understand, and willing to provide written informed consent.
•3. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
•4. Diagnosis of chronic heart failure in NYHA class II or III
•5. Able to stand for 2 minutes
•6. Access to necessary resources for participating in a technology-based intervention (smartphone, blood pressure monitor, internet access).

Exclusion Criteria

•The participant may not enter the study if ANY of the following apply:
•1. Use of other services for telemedical monitoring for heart failure.
•2. Renal failure with a Glomerular Filtration Rate (GFR) \<25 ml/min or requiring renal replacement therapy.
•3. Pregnancy, female participant lactating or planning pregnancy during the course of the trial.
•4. Complex congenital heart disease
•5. Subjects with known pulmonary hypertension (WHO category 1 or 3/4/5)
•6. Inability to perform regular measurements alone or with help of a caregiver.
•7. Other possible unforeseen medical conditions that the investigator deems unsafe for study participation.

Locations (1)

Premedix Clinic

Bratislava, Nové Mesto, Slovakia

Key Dates

Start Date

May 1, 2024

Primary Completion Date

October 1, 2025

Completion Date

November 1, 2025

Last Updated

December 18, 2025

Enrollment

330

ACTUAL participants

Conditions

Heart FailureRemote Monitoring

Interventions

Seerlinq Telemedical Monitoring System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Strategy TO Prevent Decompensated Heart Failure

Inclusion Criteria

Exclusion Criteria

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