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| Name | Class |
|---|---|
| Premedix Academy | OTHER |
| Premedix Clinic | UNKNOWN |
| Dôvera zdravotná poisťovňa, a.s. | UNKNOWN |
| LA-RO COR |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seerlinq intervention arm | Experimental | Participants in the intervention arm will be haemodynamically-guided based on the results from the Seerlinq telemedical monitoring system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. . |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalizations for HF | Rate of heart failure hospitalization in 6 month | in 6 months |
| Medication changes | Any medication changes triggered by remote monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Health care costs | Total healthcare costs per patient associated with management during the average 6-month follow-up period. | in 6 month |
| Incremental cost-effectiveness ratio | Incremental cost-effectiveness ratio (ICER): cost per avoided heart-failure hospitalization or all-cause mortality event at 6 months. |
Inclusion Criteria
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Allan Böhm, MD | Seerlinq | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premedix Clinic | Bratislava | Nové Mesto | 831 01 | Slovakia |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| UNKNOWN |
| KardioNitra Ambulancia | UNKNOWN |
| Nemocnica s poliklinikou, Nové Mesto nad Váhom, n. o. | UNKNOWN |
| Kardiologia KK | UNKNOWN |
| Interná a kardiologická ambulancia Trebišov, spol. s r.o. | UNKNOWN |
| Nemocnica Hlohovec | UNKNOWN |
| KCNR | UNKNOWN |
| Kardiocomp | UNKNOWN |
| Mydliar Intermedical | UNKNOWN |
| Súscch | UNKNOWN |
| NAW - Nemocnica Piestany | UNKNOWN |
| IMCORE, s.r.o | UNKNOWN |
| Diagnos - SM, s.r.o. | UNKNOWN |
| Interna a diabetologicka ambulancia Skalica | UNKNOWN |
| UPJS Kosice | UNKNOWN |
| BalMedic s.r.o. | UNKNOWN |
| SUSCCH | UNKNOWN |
| KCNR - Trnava / Nemocnica NMnV | UNKNOWN |
| FN Trenčín | UNKNOWN |
| K+R | UNKNOWN |
| DevinAmb / Kardio-Sanus | UNKNOWN |
| UNB Ruzinov | UNKNOWN |
| Nemocnica s poliklinikou v Rožňave - Penta Hospitals | UNKNOWN |
| NemoSan | UNKNOWN |
| Duo Medical sro | UNKNOWN |
| Valys s.r.o. | UNKNOWN |
| CARDIOCONSULT s.r.o. | UNKNOWN |
| Sciens s.r.o. | UNKNOWN |
| NsP Bardejov | UNKNOWN |
| KCNR, Kardiologická ambulancia, Trnava | UNKNOWN |
| FNsP J. A. Reimana Prešov | UNKNOWN |
| NUSCH | UNKNOWN |
| FN Nitra | UNKNOWN |
| Poliklinika Karlova Ves | UNKNOWN |
| Nemocnica s Poliklinikou Čadca | UNKNOWN |
| Nemocnica Staré mesto - UNB - Mickiewiczova | UNKNOWN |
| Nemocnica Poprad | UNKNOWN |
| Semper Cor s.r.o. | UNKNOWN |
| Nemocnica Milosrdni Bratia | UNKNOWN |
| MediKardio | UNKNOWN |
| CorDei | UNKNOWN |
| NNG Bory | UNKNOWN |
| Nemocnica Považská Bystrica | UNKNOWN |
| NsP Sv. Jakuba, n.o., Bardejov | UNKNOWN |
| Ščasná, s.r.o. | UNKNOWN |
| NSP Myjava | UNKNOWN |
| Nemocnica Partizánske | UNKNOWN |
| Dom srdca s.r.o. | UNKNOWN |
| Nemocnica s poliklinikou Dunajská Streda, a.s. | UNKNOWN |
| CorArt s.r.o. | UNKNOWN |
| Nemocnica Malacky | UNKNOWN |
| Solikcardiology | UNKNOWN |
| Samaria | UNKNOWN |
| NspBr | UNKNOWN |
| East Slovak Institute for Cardiovascular Diseases | OTHER |
| KARDIOPREVENT | UNKNOWN |
| Sabimed | UNKNOWN |
| Fakultná nemocnica s poliklinikou Nové Zámky | UNKNOWN |
| Sukr Amb v Ružinovskej poliklinike - MUDr O.B. s.r.o. | UNKNOWN |
| Barmeda | UNKNOWN |
| MD clinic | UNKNOWN |
| Marmedico | UNKNOWN |
| Nemocnica s poliklinikou Spišská Nová Ves a.s. | UNKNOWN |
| M.K.U. Med | UNKNOWN |
| AJC MED, s.r.o. | UNKNOWN |
| Luxicor s.r.o. | UNKNOWN |
| Interna Zvolen s.r.o. | UNKNOWN |
| ŽILPO | UNKNOWN |
| INTER - KARDIO, s.r.o. | UNKNOWN |
| KVC - Kardiovaskulárne Centrum s.r.o. | UNKNOWN |
| Hospitale s.r.o. | UNKNOWN |
| Klinika Orbis | UNKNOWN |
| FNsP BB | UNKNOWN |
| Polymedica - Praha | UNKNOWN |
| Neštátna interná ambulancia - MUDr. O.K. | UNKNOWN |
| Poliklinika ŽnH | UNKNOWN |
| Veria s.r.o. | UNKNOWN |
| UNM - Univerzitná nemocnica Martin | UNKNOWN |
| Delio spol. s.r.o. | UNKNOWN |
| Ortovita | UNKNOWN |
| CINRE | UNKNOWN |
| Kardiologická ambulancia, MUDr. MG, Michalovce | UNKNOWN |
| Nemocnica Skalica | UNKNOWN |
| Operatíva, lekárska spoločnosť, spol. s r.o. | UNKNOWN |
| P&P MEDINE s.r.o. | UNKNOWN |
| Zdravie Martin s.r.o. | UNKNOWN |
| CARDIO s.r.o. | UNKNOWN |
| Kardio-Sanus | UNKNOWN |
| Kardio ZM | UNKNOWN |
| OMCOR s. r. o. | UNKNOWN |
| Kardio R s.r.o. | UNKNOWN |
| ZK Cardio ambulancia | UNKNOWN |
| UN Martin | UNKNOWN |
| REKA Kežmarok, s.r.o. | UNKNOWN |
| JM Interna | UNKNOWN |
| IV. interná klinika LF UK a UNB | UNKNOWN |
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|
| in 6 months |
| Telephone contacts | Total count of medical telephone contacts documented between investigational sites and participating patients triggered by remote monitoring. | in 6 months |
| Cardiology visits | Total number of in-person cardiology visits triggered by monitoring | in 6 months |
| Patient compliance | Patient compliance with device measurement. | in 6 month |
| in 6 months |
| Healthcare resource-utilization costs | 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 | in 6 months |
| Comparison of healthcare costs between Seerlinq-guided management and standard-of-care | 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. | in 6 month |