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Completed

NCT Number: NCT06641921

Strategy TO Prevent Decompensated Heart Failure

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Premedix Clinic

Bratislava, Nové Mesto, 831 01, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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.

Treatment and study plan

Seerlinq Telemedical Monitoring System

Device

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. .

Primary outcomes

  1. Heart failure hospitalization and mortality

    Time frame: 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 outcomes

  1. Number of hospitalizations for HF

    Time frame: in 6 months

    Rate of heart failure hospitalization in 6 month

  2. Medication changes

    Time frame: in 6 months

    Any medication changes triggered by remote monitoring

  3. Telephone contacts

    Time frame: in 6 months

    Total count of medical telephone contacts documented between investigational sites and participating patients triggered by remote monitoring.

  4. Cardiology visits

    Time frame: in 6 months

    Total number of in-person cardiology visits triggered by monitoring

  5. Patient compliance

    Time frame: in 6 month

    Patient compliance with device measurement.

Other outcomes

  1. Health care costs

    Time frame: in 6 month

    Total healthcare costs per patient associated with management during the average 6-month follow-up period.

  2. Incremental cost-effectiveness ratio

    Time frame: in 6 months

    Incremental cost-effectiveness ratio (ICER): cost per avoided heart-failure hospitalization or all-cause mortality event at 6 months.

  3. Healthcare resource-utilization costs

    Time frame: 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

  4. Comparison of healthcare costs between Seerlinq-guided management and standard-of-care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seerlinq s. r. o.

Other

Collaborators

  • AJC MED, s.r.o.
  • BalMedic s.r.o.
  • Barmeda
  • CARDIO s.r.o.
  • CARDIOCONSULT s.r.o.
  • CINRE
  • CorArt s.r.o.
  • CorDei
  • Delio spol. s.r.o.
  • DevinAmb / Kardio-Sanus
  • Diagnos - SM, s.r.o.
  • Dom srdca s.r.o.
  • Duo Medical sro
  • Dôvera zdravotná poisťovňa, a.s.
  • East Slovak Institute for Cardiovascular Diseases
  • FN Nitra
  • FN Trenčín
  • FNsP BB
  • FNsP J. A. Reimana Prešov
  • Fakultná nemocnica s poliklinikou Nové Zámky
  • Hospitale s.r.o.
  • IMCORE, s.r.o
  • INTER - KARDIO, s.r.o.
  • IV. interná klinika LF UK a UNB
  • Interna Zvolen s.r.o.
  • Interna a diabetologicka ambulancia Skalica
  • Interná a kardiologická ambulancia Trebišov, spol. s r.o.
  • JM Interna
  • K+R
  • KARDIOPREVENT
  • KCNR
  • KCNR - Trnava / Nemocnica NMnV
  • KCNR, Kardiologická ambulancia, Trnava
  • KVC - Kardiovaskulárne Centrum s.r.o.
  • Kardio R s.r.o.
  • Kardio ZM
  • Kardio-Sanus
  • KardioNitra Ambulancia
  • Kardiocomp
  • Kardiologia KK
  • Kardiologická ambulancia, MUDr. MG, Michalovce
  • Klinika Orbis
  • LA-RO COR
  • Luxicor s.r.o.
  • M.K.U. Med
  • MD clinic
  • Marmedico
  • MediKardio
  • Mydliar Intermedical
  • NAW - Nemocnica Piestany
  • NNG Bory
  • NSP Myjava
  • NUSCH
  • NemoSan
  • Nemocnica Hlohovec
  • Nemocnica Malacky
  • Nemocnica Milosrdni Bratia
  • Nemocnica Partizánske
  • Nemocnica Poprad
  • Nemocnica Považská Bystrica
  • Nemocnica Skalica
  • Nemocnica Staré mesto - UNB - Mickiewiczova
  • Nemocnica s Poliklinikou Čadca
  • Nemocnica s poliklinikou Dunajská Streda, a.s.
  • Nemocnica s poliklinikou Spišská Nová Ves a.s.
  • Nemocnica s poliklinikou v Rožňave - Penta Hospitals
  • Nemocnica s poliklinikou, Nové Mesto nad Váhom, n. o.
  • Neštátna interná ambulancia - MUDr. O.K.
  • NsP Bardejov
  • NsP Sv. Jakuba, n.o., Bardejov
  • NspBr
  • OMCOR s. r. o.
  • Operatíva, lekárska spoločnosť, spol. s r.o.
  • Ortovita
  • P&P MEDINE s.r.o.
  • Poliklinika Karlova Ves
  • Poliklinika ŽnH
  • Polymedica - Praha
  • Premedix Academy
  • Premedix Clinic
  • REKA Kežmarok, s.r.o.
  • SUSCCH
  • Sabimed
  • Samaria
  • Sciens s.r.o.
  • Semper Cor s.r.o.
  • Solikcardiology
  • Sukr Amb v Ružinovskej poliklinike - MUDr O.B. s.r.o.
  • Súscch
  • UN Martin
  • UNB Ruzinov
  • UNM - Univerzitná nemocnica Martin
  • UPJS Kosice
  • Valys s.r.o.
  • Veria s.r.o.
  • ZK Cardio ambulancia
  • Zdravie Martin s.r.o.
  • Ščasná, s.r.o.
  • ŽILPO

Registry information

Official study title

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.

Acronym: #STOP-DHF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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