Clinical trial NCT06649435: Seerlinq: Non-invasive LVFP Monitoring in HF
Official title: Seerlinq: a Non-invasive System for Remote Monitoring of Left Ventricular Filling Pressure in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Photoplethysmography
Right Heart Catheterization
Keywords: heart failure
photoplethysmography
right heart catheterization
Lead sponsor: Seerlinq s. r. o.
Sponsor class: OTHER
Collaborators: name: Premedix Academy
First posted: 2024-10-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 150 adult participants aged ≥ 18 years with diagnosed HF and 150 healthy volunteers fulfilling all the inclusion and none of the exclusion criteria.

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.

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.

Eligibility criteria: 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
* Healthy volunteer

Exclusion Criteria:

* Pregnancy or female participant lactating
* Other possible unforeseen medical conditions that the investigator deems unsafe for study participation

Primary outcomes:
measure: Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.
timeFrame: in 1 year
measure: Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the RHC studies.
timeFrame: in 1 year
measure: LVFP changes post-diuretic up-titration in the remote monitoring analysis, evaluating its role in monitoring treatment response.
timeFrame: in 1 year
Secondary outcomes:
measure: The correlation between LVFP determined by PPG analysis by the Seerlinq HeartCore and LVFP (PCWP) measured during RHC.
timeFrame: in 1 year
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Seerlinq s.r.o.
state: Nové Mesto
Study officials:
affiliation: Seerlinq
name: Allan Böhm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.