Seerlinq: Non-invasive LVFP Monitoring in HF

NCT06649435 | Completed

• 1 other identifier: 2023001
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Photoplethysmography; Right Heart Catheterization

Keywords

heart failure; photoplethysmography; right heart catheterization

Outcome Measures

Primary Outcomes (3)

• Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.

  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.

  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.

  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 Outcomes (1)

• The correlation between LVFP determined by PPG analysis by the Seerlinq HeartCore and LVFP (PCWP) measured during RHC.

  in 1 year

Study Arms (3)

RHC cohort

Patients undergoing right heart catheterization (RHC) for invasive measurement of LVFP.

Procedure: PPG measurement

ECHO cohort

Patients in whom LVFP (normal vs. elevated) will be classified non-invasively using transthoracic echocardiography (TTE).

Procedure: PPG measurement

RPM cohort

Patients participating in a pilot remote patient monitoring program with regular home-based measurements.

Interventions

PPG measurement PROCEDURE

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; RHC cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seerlinq s. r. o.: lead
• Premedix Academy: collaborator

Study Sites (1)

Seerlinq s.r.o.

Bratislava, Nové Mesto, 831 01, Slovakia

Location

Related Publications (3)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Crespo-Leiro MG, Metra M, Lund LH, Milicic D, Costanzo MR, Filippatos G, Gustafsson F, Tsui S, Barge-Caballero E, De Jonge N, Frigerio M, Hamdan R, Hasin T, Hulsmann M, Nalbantgil S, Potena L, Bauersachs J, Gkouziouta A, Ruhparwar A, Ristic AD, Straburzynska-Migaj E, McDonagh T, Seferovic P, Ruschitzka F. Advanced heart failure: a position statement of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2018 Nov;20(11):1505-1535. doi: 10.1002/ejhf.1236. Epub 2018 Jul 17.

  PMID: 29806100 BACKGROUND

• Silber HA, Trost JC, Johnston PV, Maughan WL, Wang NY, Kasper EK, Aversano TR, Bush DE. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol. 2012 May 15;302(10):H2043-7. doi: 10.1152/ajpheart.00609.2011. Epub 2012 Mar 2.

  PMID: 22389389 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Allan Böhm, MD

  Seerlinq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)