About this trial
Congestion plays a key role in heart failure (HF) trajectory .Clinical congestion refers to the signs and symptoms resulting from elevated cardiac filling pressures. Hemodynamic congestion refers to elevated cardiac filling pressures, which may occur days or weeks before the presentation of symptoms , , .
Serial assessment of congestion is required in each encounter of the HF patients, while in current clinical practice, serial assessment of congestion relies on physical examination, sometimes supported by BNP test. Both physical and BNP test are reported to be unreliable in some cases , . Echocardiography is good tool, but it requires skilled physician to operation and is more time consuming. In general, there is unmet needs of better tools for serial assessment of congestion in HF patient management.
In this study, we aim to prospectively observe and evaluate the feasibility of using a novel non-invasive device in assessment of congestion in HF patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute heart failure;Stabilized outpatient chronic heart failure patients;Willing to sign the inform consent
Disqualifiers
1.Patients under 18 years old 2.Patients with congenital heart diseases (e.g., tetralogy of Fallot, atrial septal defect, Fontan disease, single chamber disease) 3.Patients with implanted artificial mechanical valves, pacemaker or ICD. 4.Patients with significant back issues that prevent them from lying supine on the bed 5.Pregnant patients 6.Patient wight under 35 kg or over 150 kg 7.Patients who are attaching to other medical device that prevent them to receive a test by the study device.
Trial population
Patient visits to hospital with suspected heart failure (HF) or with history of HF were enrolled. Some of the patients were admitted to cardiology ward due to initial diagnosis of acute heart failure (AHF). Some of the patients are who make a planned visit to outpatient clinic with history of HF. All patients are over 18 years old and are willing to sign the inform consent.
Trial design
Case-control
Prospective
Treatments tested in this trial
Assess Non-invasive filling pressure(NIFP) in heart failure patients
DeviceAssess Non-invasive filling pressure(NIFP) in outpatients with stable heart failure and inpatients with acute heart failure in ward
Treatment groups
Trial outcomes
Primary outcomes
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
Noninvasive filling pressure testing has clinical significance consistent with NT-proBNP and CCS scores to reflect congestion in acute heart failure.
Sponsors and contacts
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The University of Hong Kong-Shenzhen Hospital
Lead sponsor
Shenzhen Fiber Medical Technology Co., Ltd.
Collaborator