NCT06641921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

October 8, 2024

Last Update Submit

December 11, 2025

Conditions

Heart FailureRemote Monitoring

Keywords

heart failureremote monitoringphotoplethysmographytelemedicine

Outcome Measures

Primary Outcomes (1)

  • Heart failure hospitalization and mortality

    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 %

    in 6 months

Secondary Outcomes (5)

  • Number of hospitalizations for HF

    in 6 months

  • Medication changes

    in 6 months

  • Telephone contacts

    in 6 months

  • Cardiology visits

    in 6 months

  • Patient compliance

    in 6 month

Other Outcomes (4)

  • Health care costs

    in 6 month

  • Incremental cost-effectiveness ratio

    in 6 months

  • Healthcare resource-utilization costs

    in 6 months

  • +1 more other outcomes

Study Arms (1)

Seerlinq intervention arm

EXPERIMENTAL

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

Device: Seerlinq Telemedical Monitoring System

Interventions

Seerlinq Telemedical Monitoring SystemDEVICE

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. .

Seerlinq intervention arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Premedix Clinic

Bratislava, Nové Mesto, 831 01, Slovakia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Allan Böhm, MD

    Seerlinq

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

May 1, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

SL(1)