Heart Failure Clinical Trial

Hemodynamic Assessment in Acute Decompensated Heart Failure

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Admission to the hospital with a primary diagnosis of acute decompensated heart failure
Treated with or planned treatment with intravenous diuretics

Volume overload, as indicated by at least one of the following clinical signs:

Peripheral edema
Pulmonary edema on physical examination
Pleural effusions on chest x-ray
Jugular venous distension on physical examination
CVP > 10 cmH2O
Presence of third heart sound
Able to understand study procedures, agree to participate in the study program and voluntarily provide written informed consent

Exclusion Criteria:

Inability or refusal to sign the Subject Informed Consent
Age > 80 years
Body mass index (BMI) > 40
Planned mechanical ventilation during hospitalization
Presence of left ventricular assist device (LVAD)
Dialysis
Pregnancy. All women of childbearing potential must have a negative pregnancy test before enrollment.
Parenteral diuretic or other medical treatment for ADHF already administered for more than 12 hours prior to enrollment
Skin damage to the optical sampling sites (fingers and dorsal hand), to include tattoos, scars, cuts, or burns extending over more than 30% of the visible tissue
Compromised superficial hand veins or proximal venous stenosis
Intravenous lines connected to both arms
Inability to stand with support, if needed, for 4 minutes
Inability to place hand in the venous imaging enclosure due to forearm, elbow, or shoulder injuries, or other physical constraints
Inability to wear fingertip or ring sensors on three fingers (of either hand) due to missing fingers, injured fingers, or other physical constraints
Persons in police custody or prisoners
Major medical or psychiatric condition that would interfere with the ability to complete the study

Study is for people with:

Heart Failure

Estimated Enrollment:

5

Study ID:

NCT03535909

Recruitment Status:

Completed

Sponsor:

Rodin Scientific LLC

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There are 2 Locations for this study

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New Mexico Heart Institute
Albuquerque New Mexico, 87102, United States
University Hospital of Split
Split , 21 00, Croatia

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

5

Study ID:

NCT03535909

Recruitment Status:

Completed

Sponsor:


Rodin Scientific LLC

How clear is this clinincal trial information?

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