Seerlinq: Non-invasive LVFP Monitoring in HF (PPG-HF)

November 17, 2025 updated by: Seerlinq s. r. o.

Seerlinq: a Non-invasive System for Remote Monitoring of Left Ventricular Filling Pressure in Heart Failure Patients

Left ventricular filling pressure (LVFP) monitoring has been associated with improved quality of life, survival and reduced hospitalization rates. However, current LVFP monitoring methods are invasive, costly, and require long-term antithrombotic therapy.

The purpose of this study is to validate Seerlinq HeartCore, a novel CE-certified, non-invasive system that enables remote LVFP monitoring using photoplethysmography (PPG) and machine learning-based signal analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) affects approximately 1-2% of the adult population in developed countries, with prevalence exceeding 10% among individuals older than 70 years. Despite advancements in diagnostics and treatment guided by evidence-based medicine, HF remains associated with high morbidity and mortality; up to 17% of patients die and up to 44% require hospitalization within 12 months.

Monitoring of left ventricular filling pressure (LVFP) has been shown to improve survival, quality of life, and reduce hospitalization rates in patients with HF. However, existing methods for LVFP assessment are invasive, costly, and require long-term antithrombotic therapy, limiting their widespread application.

The purpose of this study is to validate HeartCore, a novel CE-certified, non-invasive system that enables remote LVFP monitoring using photoplethysmography (PPG) combined with machine learning-based signal analysis.

This will be a prospective, multicenter study enrolling three patient cohorts:

RHC cohort, ECHO cohort, and RPM cohort. Participants will undergo 120-second PPG recordings in both upright and supine positions using a standard pulse oximeter connected to a smartphone. The PPG signals will be transmitted to a secure server and processed by the HeartCore algorithm to estimate LVFP, expressed as the diastolic reserve index (DRI), where a higher DRI indicates lower LVFP.

The primary outcomes of the study will be:

  • The discrimination performance of the PPG-based HeartCore system for detecting elevated LVFP in the RHC and ECHO cohorts, measured by receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity.
  • The change in DRI following furosemide up-titration in the RPM cohort.

The secondary outcome will be:

• The correlation between DRI and pulmonary capillary wedge pressure (PCWP) in the RHC cohort.

This study aims to demonstrate that a non-invasive, widely available, and scalable PPG-based system can provide reliable assessment of LVFP in HF patients, potentially improving the management and outcomes of this population.

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
    • Nové Mesto
      • Bratislava, Nové Mesto, Slovakia, 831 01
        • Seerlinq s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 131 adult participants aged ≥ 18 years with diagnosed HF, enrolled into three cohorts - RHC, ECHO, RPM, fulfilling all the inclusion and none of the exclusion criteria.

Description

Inclusion Criteria:

  • Males and females aged ≥ 18 years
  • Able to understand, and willing to provide written ICF
  • Stated willingness to comply with all study procedures
  • Confirmed diagnosis of heart failure according to the 2021 ESC guidelines

Exclusion Criteria:

  • Pregnancy or female participant lactating
  • Advanced renal failure (glomerular filtration rate <25 ml/min or need for renal replacement therapy),
  • Active malignancy requiring chemotherapy or radiotherapy
  • Complex congenital heart disease
  • Ventricular assist device support
  • Pulmonary hypertension classified as WHO group 1 or groups 3-5.
  • Other possible unforeseen medical conditions that the investigator deems unsafe for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RHC cohort
Patients undergoing right heart catheterization (RHC) for invasive measurement of LVFP.
Procedure: PPG measurement

PPG signal will be measured on CE certified medical devices. Two measurements will be performed - standing and in the recumbent position using reflectance and transmitance method on finger and in ear canal. The each measurement will be 120s long.

Detailed analysis of PPG signal and pathophysiological phenomena associated with HF - peripheral volume changes detectable in PPG signal - will help to understand better and clarify the pathophysiological mechanisms of peripheral volume changes in a failing heart.
ECHO cohort
Patients in whom LVFP (normal vs. elevated) will be classified non-invasively using transthoracic echocardiography (TTE).
Procedure: PPG measurement

PPG signal will be measured on CE certified medical devices. Two measurements will be performed - standing and in the recumbent position using reflectance and transmitance method on finger and in ear canal. The each measurement will be 120s long.

Detailed analysis of PPG signal and pathophysiological phenomena associated with HF - peripheral volume changes detectable in PPG signal - will help to understand better and clarify the pathophysiological mechanisms of peripheral volume changes in a failing heart.
RPM cohort
Patients participating in a pilot remote patient monitoring program with regular home-based measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.
Time Frame: in 1 year
The ability to distinguish elevated left ventricular filling pressure (LVFP) will be assessed using receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity metrics in echocardiogram (ECHO) studies. This evaluation aims to validate the diagnostic accuracy of the proposed method.
in 1 year
Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the RHC studies.
Time Frame: in 1 year
The ability to distinguish elevated left ventricular filling pressure (LVFP) will be assessed using receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity metrics in right heart catheterization (RHC) studies. This evaluation aims to validate the diagnostic accuracy of the proposed method.
in 1 year
LVFP changes post-diuretic up-titration in the remote monitoring analysis, evaluating its role in monitoring treatment response.
Time Frame: in 1 year
Changes in left ventricular filling pressure (LVFP) following diuretic up-titration will be analyzed through remote monitoring to assess its effectiveness in tracking treatment response. The change in LVFP (DRI) pre- and post-treatment adjustment will be compared using appropriate statistical method. This endpoint will explore the utility of continuous monitoring in optimizing heart failure management.
in 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between LVFP determined by PPG analysis by the Seerlinq HeartCore and LVFP (PCWP) measured during RHC.
Time Frame: in 1 year
The correlation between left ventricular filling pressure (LVFP) estimated via photoplethysmography (PPG) analysis using the Seerlinq HeartCore device and LVFP (pulmonary capillary wedge pressure, PCWP) measured during right heart catheterization (RHC) will be evaluated. This correlation will help validate the PPG-based method as a non-invasive alternative for LVFP assessment.
in 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup analysis
Time Frame: in 1 year
o perform a validation of the Seerlinq HeartCore algorithm for classification of LVFP (normal vs. elevated) in HF patients.
in 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seerlinq s. r. o.

Collaborators

Premedix Academy

Investigators

  • Principal Investigator: Allan Böhm, MD, Seerlinq

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023001 (SUN Yat-sen University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on PPG measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe