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NCT06641921

Strategy TO Prevent Decompensated Heart Failure

NCT ID: NCT06641921

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Heart Failure Remote Monitoring

Keywords

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heart failure remote monitoring photoplethysmography telemedicine

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Seerlinq intervention arm

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

Group Type EXPERIMENTAL

Seerlinq Telemedical Monitoring System

Intervention Type 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. .

Interventions

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Seerlinq Telemedical Monitoring System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Males and females aged ≥ 18 years.
2. Able to understand, and willing to provide written informed consent.
3. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
4. Diagnosis of chronic heart failure in NYHA class II or III
5. Able to stand for 2 minutes
6. 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:

1. Use of other services for telemedical monitoring for heart failure.
2. Renal failure with a Glomerular Filtration Rate (GFR) \<25 ml/min or requiring renal replacement therapy.
3. Pregnancy, female participant lactating or planning pregnancy during the course of the trial.
4. Complex congenital heart disease
5. Subjects with known pulmonary hypertension (WHO category 1 or 3/4/5)
6. Inability to perform regular measurements alone or with help of a caregiver.
7. Other possible unforeseen medical conditions that the investigator deems unsafe for study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allan Böhm, MD

Role: PRINCIPAL_INVESTIGATOR

Seerlinq

Locations

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Premedix Clinic

Bratislava, Nové Mesto, Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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012024

Identifier Type: -

Identifier Source: org_study_id

Strategy TO Prevent Decompensated Heart Failure

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Seerlinq intervention arm

Seerlinq Telemedical Monitoring System

Interventions

Seerlinq Telemedical Monitoring System

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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