Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641921
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Strategy to Prevent Decompensated Heart Failure
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-DHF
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 patients 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
Study hypothesis
Haemodynamically-guided HF treatment using the Seerlinq telemedical monitoring will improve patients 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 62 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 patients 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 patients 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 patients treatment to prevent negative outcomes of HF
Heart failure affects more than 62 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 patients 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 patients 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 patients treatment to prevent negative outcomes of HF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None