NCT06641921Completed
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.
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 330 (actual)
- First submitted
- 8 Oct 2024
- Start date
- 1 May 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Seerlinq s. r. o.
- Diseases
- Heart failure
- NCT number
- NCT06641921
What you commit to
- Study type: Interventional
- Participants enrolled: 330
- From 1 May 2024 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Use of other services for telemedical monitoring for heart failure.
- Complex congenital heart disease
- Subjects with known pulmonary hypertension (WHO category 1 or 3/4/5)
- Other possible unforeseen medical conditions that the investigator deems unsafe for study participation.
Lab values
- Renal failure with a Glomerular Filtration Rate (GFR) \<25 ml/min or requiring renal replacement therapy.
Other
- The participant may not enter the study if ANY of the following apply:
- Pregnancy, female participant lactating or planning pregnancy during the course of the trial.
- Inability to perform regular measurements alone or with help of a caregiver.
Who the study is looking for
- Males and females aged ≥ 18 years.
- Able to understand, and willing to provide written informed consent.
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
- Diagnosis of chronic heart failure in NYHA class II or III
- Able to stand for 2 minutes
- Access to necessary resources for participating in a technology-based intervention (smartphone, blood pressure monitor, internet access).
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Premedix Clinic Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.