Strategy TO Prevent Decompensated Heart Failure

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.

Conditions

• Heart Failure
• Remote Monitoring

Interventions

DEVICE

Seerlinq Telemedical Monitoring System

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. .

Sponsors & Collaborators

• Premedix Academy

  collaborator OTHER

• Premedix Clinic

  collaborator UNKNOWN

• Dôvera zdravotná poisťovňa, a.s.

  collaborator UNKNOWN

• LA-RO COR

  collaborator UNKNOWN

• KardioNitra Ambulancia

  collaborator UNKNOWN

• Nemocnica s poliklinikou, Nové Mesto nad Váhom, n. o.

  collaborator UNKNOWN

• Kardiologia KK

  collaborator UNKNOWN

• Interná a kardiologická ambulancia Trebišov, spol. s r.o.

  collaborator UNKNOWN

• Nemocnica Hlohovec

  collaborator UNKNOWN

• KCNR

  collaborator UNKNOWN

• Kardiocomp

  collaborator UNKNOWN

• Mydliar Intermedical

  collaborator UNKNOWN

• Súscch

  collaborator UNKNOWN

• NAW - Nemocnica Piestany

  collaborator UNKNOWN

• IMCORE, s.r.o

  collaborator UNKNOWN

• Diagnos - SM, s.r.o.

  collaborator UNKNOWN

• Interna a diabetologicka ambulancia Skalica

  collaborator UNKNOWN

• UPJS Kosice

  collaborator UNKNOWN

• BalMedic s.r.o.

  collaborator UNKNOWN

• SUSCCH

  collaborator UNKNOWN

• KCNR - Trnava / Nemocnica NMnV

  collaborator UNKNOWN

• FN Trenčín

  collaborator UNKNOWN

• K+R

  collaborator UNKNOWN

• DevinAmb / Kardio-Sanus

  collaborator UNKNOWN

• UNB Ruzinov

  collaborator UNKNOWN

• Nemocnica s poliklinikou v Rožňave - Penta Hospitals

  collaborator UNKNOWN

• NemoSan

  collaborator UNKNOWN

• Duo Medical sro

  collaborator UNKNOWN

• Valys s.r.o.

  collaborator UNKNOWN

• CARDIOCONSULT s.r.o.

  collaborator UNKNOWN

• Sciens s.r.o.

  collaborator UNKNOWN

• NsP Bardejov

  collaborator UNKNOWN

• KCNR, Kardiologická ambulancia, Trnava

  collaborator UNKNOWN

• FNsP J. A. Reimana Prešov

  collaborator UNKNOWN

• NUSCH

  collaborator UNKNOWN

• FN Nitra

  collaborator UNKNOWN

• Poliklinika Karlova Ves

  collaborator UNKNOWN

• Nemocnica s Poliklinikou Čadca

  collaborator UNKNOWN

• Nemocnica Staré mesto - UNB - Mickiewiczova

  collaborator UNKNOWN

• Nemocnica Poprad

  collaborator UNKNOWN

• Semper Cor s.r.o.

  collaborator UNKNOWN

• Nemocnica Milosrdni Bratia

  collaborator UNKNOWN

• MediKardio

  collaborator UNKNOWN

• CorDei

  collaborator UNKNOWN

• NNG Bory

  collaborator UNKNOWN

• Nemocnica Považská Bystrica

  collaborator UNKNOWN

• NsP Sv. Jakuba, n.o., Bardejov

  collaborator UNKNOWN

• Ščasná, s.r.o.

  collaborator UNKNOWN

• NSP Myjava

  collaborator UNKNOWN

• Nemocnica Partizánske

  collaborator UNKNOWN

• Dom srdca s.r.o.

  collaborator UNKNOWN

• Nemocnica s poliklinikou Dunajská Streda, a.s.

  collaborator UNKNOWN

• CorArt s.r.o.

  collaborator UNKNOWN

• Nemocnica Malacky

  collaborator UNKNOWN

• Solikcardiology

  collaborator UNKNOWN

• Samaria

  collaborator UNKNOWN

• NspBr

  collaborator UNKNOWN

• East Slovak Institute for Cardiovascular Diseases

  collaborator OTHER

• KARDIOPREVENT

  collaborator UNKNOWN

• Sabimed

  collaborator UNKNOWN

• Fakultná nemocnica s poliklinikou Nové Zámky

  collaborator UNKNOWN

• Sukr Amb v Ružinovskej poliklinike - MUDr O.B. s.r.o.

  collaborator UNKNOWN

• Barmeda

  collaborator UNKNOWN

• MD clinic

  collaborator UNKNOWN

• Marmedico

  collaborator UNKNOWN

• Nemocnica s poliklinikou Spišská Nová Ves a.s.

  collaborator UNKNOWN

• M.K.U. Med

  collaborator UNKNOWN

• AJC MED, s.r.o.

  collaborator UNKNOWN

• Luxicor s.r.o.

  collaborator UNKNOWN

• Interna Zvolen s.r.o.

  collaborator UNKNOWN

• ŽILPO

  collaborator UNKNOWN

• INTER - KARDIO, s.r.o.

  collaborator UNKNOWN

• KVC - Kardiovaskulárne Centrum s.r.o.

  collaborator UNKNOWN

• Hospitale s.r.o.

  collaborator UNKNOWN

• Klinika Orbis

  collaborator UNKNOWN

• FNsP BB

  collaborator UNKNOWN

• Polymedica - Praha

  collaborator UNKNOWN

• Neštátna interná ambulancia - MUDr. O.K.

  collaborator UNKNOWN

• Poliklinika ŽnH

  collaborator UNKNOWN

• Veria s.r.o.

  collaborator UNKNOWN

• UNM - Univerzitná nemocnica Martin

  collaborator UNKNOWN

• Delio spol. s.r.o.

  collaborator UNKNOWN

• Ortovita

  collaborator UNKNOWN

• CINRE

  collaborator UNKNOWN

• Kardiologická ambulancia, MUDr. MG, Michalovce

  collaborator UNKNOWN

• Nemocnica Skalica

  collaborator UNKNOWN

• Operatíva, lekárska spoločnosť, spol. s r.o.

  collaborator UNKNOWN

• P&P MEDINE s.r.o.

  collaborator UNKNOWN

• Zdravie Martin s.r.o.

  collaborator UNKNOWN

• CARDIO s.r.o.

  collaborator UNKNOWN

• Kardio-Sanus

  collaborator UNKNOWN

• Kardio ZM

  collaborator UNKNOWN

• OMCOR s. r. o.

  collaborator UNKNOWN

• Kardio R s.r.o.

  collaborator UNKNOWN

• ZK Cardio ambulancia

  collaborator UNKNOWN

• UN Martin

  collaborator UNKNOWN

• REKA Kežmarok, s.r.o.

  collaborator UNKNOWN

• JM Interna

  collaborator UNKNOWN

• IV. interná klinika LF UK a UNB

  collaborator UNKNOWN

• Seerlinq s. r. o.

  lead OTHER

Principal Investigators

• Allan Böhm, MD · Seerlinq

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-10-01

Completion

2025-11-01

Countries

• Slovakia

Study Locations