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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06641921

Acronym

#STOP-DHF

Enrollment

330

Registered

2024-10-15

Start date

2024-05-01

Completion date

2025-11-01

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Remote Monitoring

Keywords

heart failure, remote monitoring, photoplethysmography, telemedicine

Brief 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

Interventions

DEVICESeerlinq 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. .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Heart failure hospitalization and mortality	in 6 months	Composite incidence of heart-failure hospitalization or all-cause mortality during an average follow-up of 6 months, assessed against a prespecified performance goal (PG) of 9.0 %

Secondary

Measure	Time frame	Description
Medication changes	in 6 months	Any medication changes triggered by remote monitoring
Number of hospitalizations for HF	in 6 months	Rate of heart failure hospitalization in 6 month
Telephone contacts	in 6 months	Total count of medical telephone contacts documented between investigational sites and participating patients triggered by remote monitoring.
Cardiology visits	in 6 months	Total number of in-person cardiology visits triggered by monitoring
Patient compliance	in 6 month	Patient compliance with device measurement.

Other

Measure	Time frame	Description
Healthcare resource-utilization costs	in 6 months	Healthcare resource-utilization costs per patient, including expenditures for heart-failure hospitalizations, emergency-department visits, outpatient consultations, and medication adjustments over the follow-up period
Comparison of healthcare costs between Seerlinq-guided management and standard-of-care	in 6 month	Comparison of total healthcare costs per patient between Seerlinq-guided management and the propensity score-matched standard-of-care (SOC) cohort over the same follow-up duration.
Incremental cost-effectiveness ratio	in 6 months	Incremental cost-effectiveness ratio (ICER): cost per avoided heart-failure hospitalization or all-cause mortality event at 6 months.
Health care costs	in 6 month	Total healthcare costs per patient associated with management during the average 6-month follow-up period.

Countries

Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026