Heart Failure#STOP-DHFNCT06641921
Strategy TO Prevent Decompensated Heart Failure
A study testing Seerlinq Telemedical Monitoring System in people with Heart Failure and Remote Monitoring, run by Seerlinq s. r. o. at 1 site in Slovakia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure, Remote Monitoring
- What is being tested?
- Seerlinq Telemedical Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 May 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
Protocol amendment: follow-up was extended from 6 to 12 months by protocol amendment. With this amendment, the primary endpoint became the 12-month composite of heart failure hospitalisation or all-cause death; the original 6-month composite is retained as a secondary outcome.
- Conditions
- Heart Failure, Remote Monitoring
- Being tested
- Seerlinq Telemedical Monitoring System
- Keywords
- heart failure, remote monitoring, photoplethysmography, telemedicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. .
| Study group | Role | What they receive |
|---|---|---|
| Seerlinq intervention arm | Experimental | Participants in the intervention arm will be haemodynamically-guided based on the results from the Seerlinq telemedical monitoring system. Receives: Device: Seerlinq Telemedical Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure hospitalization and mortality
Composite incidence of heart-failure hospitalization or all-cause mortality during an average follow-up of 12 months, assessed against a prespecified performance goal (PG).
Measured: in 12 months
Secondary outcomes (5)
Number of hospitalizations for HF
Rate of heart failure hospitalization in 12 month
Measured: in 12 months
Medication changes
Any medication changes triggered by remote monitoring
Measured: in 12 months
Telephone contacts
Total count of medical telephone contacts documented between investigational sites and participating patients triggered by remote monitoring.
Measured: in 12 months
Cardiology visits
Total number of in-person cardiology visits triggered by monitoring
Measured: in 12 months
Patient compliance
Patient compliance with device measurement.
Measured: in 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 May 2024
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seerlinq s. r. o.
- Sponsor type
- University, hospital or other
- Collaborators
- Premedix Academy, Premedix Clinic, Dôvera zdravotná poisťovňa, a.s., LA-RO COR, KardioNitra Ambulancia, Nemocnica s poliklinikou, Nové Mesto nad Váhom, n. o., Kardiologia KK, Interná a kardiologická ambulancia Trebišov, spol. s r.o., Nemocnica Hlohovec, KCNR, Kardiocomp, Mydliar Intermedical, Súscch, NAW - Nemocnica Piestany, IMCORE, s.r.o, Diagnos - SM, s.r.o., Interna a diabetologicka ambulancia Skalica, UPJS Kosice, BalMedic s.r.o., SUSCCH, KCNR - Trnava / Nemocnica NMnV, FN Trenčín, K+R, DevinAmb / Kardio-Sanus, UNB Ruzinov, Nemocnica s poliklinikou v Rožňave - Penta Hospitals, NemoSan, Duo Medical sro, Valys s.r.o., CARDIOCONSULT s.r.o., Sciens s.r.o., NsP Bardejov, KCNR, Kardiologická ambulancia, Trnava, FNsP J. A. Reimana Prešov, NUSCH, FN Nitra, Poliklinika Karlova Ves, Nemocnica s Poliklinikou Čadca, Nemocnica Staré mesto - UNB - Mickiewiczova, Nemocnica Poprad, Semper Cor s.r.o., Nemocnica Milosrdni Bratia, MediKardio, CorDei, NNG Bory, Nemocnica Považská Bystrica, NsP Sv. Jakuba, n.o., Bardejov, Ščasná, s.r.o., NSP Myjava, Nemocnica Partizánske, Dom srdca s.r.o., Nemocnica s poliklinikou Dunajská Streda, a.s., CorArt s.r.o., Nemocnica Malacky, Solikcardiology, Samaria, NspBr, East Slovak Institute for Cardiovascular Diseases, KARDIOPREVENT, Sabimed, Fakultná nemocnica s poliklinikou Nové Zámky, Sukr Amb v Ružinovskej poliklinike - MUDr O.B. s.r.o., Barmeda, MD clinic, Marmedico, Nemocnica s poliklinikou Spišská Nová Ves a.s., M.K.U. Med, AJC MED, s.r.o., Luxicor s.r.o., Interna Zvolen s.r.o., ŽILPO, INTER - KARDIO, s.r.o., KVC - Kardiovaskulárne Centrum s.r.o., Hospitale s.r.o., Klinika Orbis, FNsP BB, Polymedica - Praha, Neštátna interná ambulancia - MUDr. O.K., Poliklinika ŽnH, Veria s.r.o., UNM - Univerzitná nemocnica Martin, Delio spol. s.r.o., Ortovita, CINRE, Kardiologická ambulancia, MUDr. MG, Michalovce, Nemocnica Skalica, Operatíva, lekárska spoločnosť, spol. s r.o., P&P MEDINE s.r.o., Zdravie Martin s.r.o., CARDIO s.r.o., Kardio-Sanus, Kardio ZM, OMCOR s. r. o., Kardio R s.r.o., ZK Cardio ambulancia, UN Martin, REKA Kežmarok, s.r.o., JM Interna, IV. interná klinika LF UK a UNB
- Responsible party
- Sponsor
- Investigators
- Allan Böhm, MD, Principal investigator, Seerlinq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641921
- Sponsor's protocol ID
- 012024
- Acronym
- #STOP-DHF
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06641921
- Acronym / sponsor ID
- #STOP-DHF / 012024
- Conditions
- Heart Failure, Remote Monitoring
- Keywords
- heart failure, remote monitoring, photoplethysmography, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Seerlinq s. r. o.University, hospital or other
- Collaborators
- Premedix Academy, Premedix Clinic, Dôvera zdravotná poisťovňa, a.s., LA-RO COR, KardioNitra Ambulancia, Nemocnica s poliklinikou, Nové Mesto nad Váhom, n. o., Kardiologia KK, Interná a kardiologická ambulancia Trebišov, spol. s r.o., Nemocnica Hlohovec, KCNR, Kardiocomp, Mydliar Intermedical, Súscch, NAW - Nemocnica Piestany, IMCORE, s.r.o, Diagnos - SM, s.r.o., Interna a diabetologicka ambulancia Skalica, UPJS Kosice, BalMedic s.r.o., SUSCCH, KCNR - Trnava / Nemocnica NMnV, FN Trenčín, K+R, DevinAmb / Kardio-Sanus, UNB Ruzinov, Nemocnica s poliklinikou v Rožňave - Penta Hospitals, NemoSan, Duo Medical sro, Valys s.r.o., CARDIOCONSULT s.r.o., Sciens s.r.o., NsP Bardejov, KCNR, Kardiologická ambulancia, Trnava, FNsP J. A. Reimana Prešov, NUSCH, FN Nitra, Poliklinika Karlova Ves, Nemocnica s Poliklinikou Čadca, Nemocnica Staré mesto - UNB - Mickiewiczova, Nemocnica Poprad, Semper Cor s.r.o., Nemocnica Milosrdni Bratia, MediKardio, CorDei, NNG Bory, Nemocnica Považská Bystrica, NsP Sv. Jakuba, n.o., Bardejov, Ščasná, s.r.o., NSP Myjava, Nemocnica Partizánske, Dom srdca s.r.o., Nemocnica s poliklinikou Dunajská Streda, a.s., CorArt s.r.o., Nemocnica Malacky, Solikcardiology, Samaria, NspBr, East Slovak Institute for Cardiovascular Diseases, KARDIOPREVENT, Sabimed, Fakultná nemocnica s poliklinikou Nové Zámky, Sukr Amb v Ružinovskej poliklinike - MUDr O.B. s.r.o., Barmeda, MD clinic, Marmedico, Nemocnica s poliklinikou Spišská Nová Ves a.s., M.K.U. Med, AJC MED, s.r.o., Luxicor s.r.o., Interna Zvolen s.r.o., ŽILPO, INTER - KARDIO, s.r.o., KVC - Kardiovaskulárne Centrum s.r.o., Hospitale s.r.o., Klinika Orbis, FNsP BB, Polymedica - Praha, Neštátna interná ambulancia - MUDr. O.K., Poliklinika ŽnH, Veria s.r.o., UNM - Univerzitná nemocnica Martin, Delio spol. s.r.o., Ortovita, CINRE, Kardiologická ambulancia, MUDr. MG, Michalovce, Nemocnica Skalica, Operatíva, lekárska spoločnosť, spol. s r.o., P&P MEDINE s.r.o., Zdravie Martin s.r.o., CARDIO s.r.o., Kardio-Sanus, Kardio ZM, OMCOR s. r. o., Kardio R s.r.o., ZK Cardio ambulancia, UN Martin, REKA Kežmarok, s.r.o., JM Interna, IV. interná klinika LF UK a UNB
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Protocol amendment: follow-up was extended from 6 to 12 months by protocol amendment. With this amendment, the primary endpoint became the 12-month composite of heart failure hospitalisation or all-cause death; the original 6-month composite is retained as a secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seerlinq intervention arm | Experimental | Device: Seerlinq Telemedical Monitoring SystemParticipants in the intervention arm will be haemodynamically-guided based on the results from the Seerlinq telemedical monitoring system. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seerlinq Telemedical Monitoring SystemParticipants 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. . | Device | Seerlinq intervention arm |
Primary outcome
Heart failure hospitalization and mortality
Time frame: in 12 months
Composite incidence of heart-failure hospitalization or all-cause mortality during an average follow-up of 12 months, assessed against a prespecified performance goal (PG).
5 secondary outcomes
Number of hospitalizations for HF
Time frame: in 12 months
Medication changes
Time frame: in 12 months
Telephone contacts
Time frame: in 12 months
Cardiology visits
Time frame: in 12 months
Patient compliance
Time frame: in 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Böhm, MD principal investigator
Seerlinq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seerlinq Telemedical Monitoring System in people with Heart Failure and Remote Monitoring, run by Seerlinq s. r. o. at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure hospitalization and mortality (time frame: in 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.