Strategy TO Prevent Decompensated Heart Failure (#STOP-DHF)

Seerlinq s. r. o.

Status: Completed

Conditions: Remote Monitoring; Heart Failure

Treatments: Device: Seerlinq Telemedical Monitoring System

Study type: Interventional

Funder types: Other

Identifiers

NCT06641921

012024

Details and patient eligibility

About

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.

Full 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

Enrollment: 330 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Seerlinq intervention arm

Experimental group

Description:

Participants in the intervention arm will be haemodynamically-guided based on the results from the Seerlinq telemedical monitoring system.

Treatment:

Device: Seerlinq Telemedical Monitoring System