Hemodynamic Assessment in Acute Decompensated Heart Failure

NCT ID: NCT03535909

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-09
• Study Completion Date: 2018-07-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Split, School of Medicine

OTHER

Sponsor Role: collaborator

Rodin Scientific LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rodin Scientific

Locations

New Mexico Heart Institute

Albuquerque, New Mexico, United States

University Hospital of Split

Split, , Croatia

Countries

United States; Croatia

Other Identifiers

RS-2018-S01

Identifier Type: -

Identifier Source: org_study_id