NCT03535909

Hemodynamic Assessment in Acute Decompensated Heart Failure

Hemodynamic Assessment Throughout Diuretic Treatment in Acute Decompensated Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Rodin Scientific LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.

Detailed description

This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP. All patients enrolled in the study will first provide written informed consent to participate and then the research coordinator will check that the subject meets all study inclusion criteria and does not meet any of the study exclusion criteria. Enrolled subjects will undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over the course of their hospitalization. There will be at least eight (8) hours between assessment sessions. Each assessment session includes recording of the subject's weight, measurements with the reference devices, and measurements with the novel optical system. During the session, the subject will be assessed in the supine, sitting, and standing positions. NT-proBNP measurements will be done at the start of study participation and the end. A market research questionnaire will be administered to the subject following the first measurement session.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Noninvasive Hemodynamic Measurement System	Ability of the noninvasive hemodynamic measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure.

Timeline

• Start date: 2018-06-09
• Primary completion: 2018-06-24
• Completion: 2018-07-31
• First posted: 2018-05-24
• Last updated: 2019-03-26

Locations

2 sites across 2 countries: United States, Croatia

Regulatory

• FDA-regulated device study