Clinical trial NCT06641921: Strategy to Prevent Decompensated Heart Failure
Official title: A Prospective, Randomized, Single Blinded and End-point Blinded Study to Compare Remote Haemodynamically-guided Treatment Using the Seerlinq System Versus Standard of Care in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Remote Monitoring
Keywords: heart failure
remote monitoring
photoplethysmography
telemedicine
Lead sponsor: Seerlinq s. r. o.
Sponsor class: OTHER
Collaborators: name: Premedix Academy
First posted: 2024-10-15
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this pilot study is to explore the feasibility, safety and potential benefit of haemodynamically-guided heart failure (HF) treatment using the Seerlinq telemedical monitoring and to compare the outcomes vs. standard of care.

Study hypothesis:

Haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring will improve patient's perception of their health status and quality of life and will be more efficient compared to the standard of care.

Study objectives:

The primary objective is to compare the ability of haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring system vs. standard of care to improve patients' perception of their health status measured by a standardized questionnaire in patients with HF.

The secondary objectives:

1. To compare the efficacy of haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring system vs. standard of care in the treatment of patients with HF measured by plasmatic levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), number of hospitalizations for heart failure and cardiovascular mortality
2. To compare the ability of haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring system vs. standard of care to improve quality of life (QoL) measured by standardized questionnaire in patients with HF Tertiary objective includes comparison of the cost-effectivity of haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring system vs. standard of care in the treatment of patients with HF.

Detailed description: Background:

Heart failure affects more than 6.2 million people in the United States and has a 5-year mortality rate of approximately 42%. Due to population growth, aging, and the increasing prevalence of comorbidities, the absolute number of hospital admissions for HF is expected to increase considerably in the future. Signs and symptoms of congestion are the predominant cause of these hospital admissions. Importantly, elevated filling pressures precede HF hospitalizations by weeks. Therefore, early recognition of increased filling pressures and appropriate intervention may prevent further deterioration and hospitalizations. Current strategies for the early detection of HF exacerbation mainly involve the use of invasive intracardiac pressure measurements and the incorporation of preclinical markers of worsening HF related to autonomic adaptation, patient activity, and intrathoracic impedance into cardiac implantable electronic devices. However, these approaches are invasive and have not consistently demonstrated efficacy.

Therefore, a non-invasive and readily available diagnostic tool capable of identifying an increase in cardiac filling pressures could be precious in clinical practice. Photoplethysmography (PPG) measurement and analysis is an emerging technology that holds the potential to offer a cost-effective and scalable alternative for achieving this goal.

Rationale:

Technological progress allows the development of systems and devices that can monitor changes in a patient's health status from the comfort of their home. The measured data is then transmitted to medical centers, where it is immediately accessible to physicians. Telemedical monitoring (remote monitoring) offers several benefits, including continuous medical supervision. Typical symptoms of HF, such as edema or shortness of breath, may develop relatively suddenly. However, the deterioration of a patient's health is preceded by complex pathophysiological processes, such as an increase in heart pressure or hemodynamic changes, and redistribution of blood volume in the bloodstream.

For this purpose, Seerlinq HeartCore monitoring system was developed. The Seerlinq monitoring system is capable of identifying these changes in advance, allowing physicians to react promptly and manage the patient's treatment to prevent negative outcomes of HF.

Eligibility criteria: Inclusion Criteria:

* Males and females aged ≥ 18 years
* Able to understand, and willing to provide written informed consent
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
* Diagnosis of chronic heart failure in NYHA class III, and with at least 1 heart failure hospitalisation within the previous 6 months (defined as admission for HF longer than 6 h and/or use of i.v. diuretics) or emergency ward visit for heart failure resulting in i.v. diuretic therapy (independent of ejection fraction %)
* Access to necessary resources for participating in a technology-based intervention (blood pressure monitor, smartphone, internet access)
* Successful completion of the 30-day run-in period with completing more than 80% of planned measurements verifying the ability to operate the study application and compliance
* Insurance in Dovera a.s.

Exclusion Criteria:

* Use of other services for telemedical monitoring of heart failure
* History of renal failure with a glomerular filtration rate (GFR) \<25 ml/min refractory to diuretic therapy or requiring renal replacement therapy
* Active oncological diagnosis requiring chemotherapy or radiotherapy
* Pregnancy, female participant lactating or planning pregnancy during the trial
* Complex congenital heart disease or mechanical heart valve(s)
* Major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months prior to randomisation
* Patients scheduled for or likely to undergo heart transplantation or ventricular assist device (VAD) implantation within 6 months from randomisation
* Subjects with known pulmonary arterial hypertension (WHO category 1 or 4/5)
* Dementia or score over 10 on the short orientation memory concentration test (and with no carer support)
* Severe depression
* Other possible unforeseen medical conditions that the investigator deems unsafe for study participation

Primary outcomes:
measure: Change in patient's perception of their health status
timeFrame: in 6 months
Secondary outcomes:
measure: Change in NT-proBNP plasmatic level
timeFrame: in 3 months
measure: Change in NT-proBNP plasmatic level
timeFrame: in 6 months
measure: Change in quality of life
timeFrame: in 3 months
measure: Change in quality of life
timeFrame: in 6 months
measure: Change in quality of life
timeFrame: in 1 year
measure: Change in patient's perception of their health status
timeFrame: in 3 months
measure: Change in patient's perception of their health status
timeFrame: in 1 year
measure: Time to first hospitalization for heart failure
timeFrame: up to 1 year
measure: Number of hospitalizations for heart failure
timeFrame: up to 1 year
measure: Time to death
timeFrame: up to 1 year
measure: Cardiovascular mortality
timeFrame: up to 1 year
measure: Days alive outside hospital
timeFrame: up to 1 year
measure: Number of contacts between sites and study patients
timeFrame: up to 1 year
Other outcomes:
measure: Incremental cost effectivity ratio and total costs associated with patient treatment
timeFrame: in 2 years
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: