Seerlinq: Non-invasive LVFP Monitoring in HF

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

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Photoplethysmography Right Heart Catheterization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RHC cohort

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

PPG measurement

Intervention Type 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

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

PPG measurement

Intervention Type 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.

RPM cohort

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

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No