Hemodynamic Assessment in Acute Decompensated Heart Failure

NCT03535909 | Completed FDA Device

• 1 other identifier: RS-2018-S01
• Study Type: observational
• Target: 5
• Locations: 2 countries
• Sites: 2

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.

Conditions

Congestive Heart Failure

Keywords

CHF; central venous pressure; noninvasive; ADHF; stroke volume

Outcome Measures

Primary Outcomes (1)

• Accuracy of Estimated Changes in Stroke Volume

  Comparison of Stroke Volume Measurement (units of ml) from the optical measurement system with paired Stroke Volume Measurement (ml) from the reference device. Accuracy will be measured in percentage error and Bland-Altman limits of agreement.

  Retrospective up to 6 months after study completion

Secondary Outcomes (1)

• Accuracy of Central Venous Pressure Measurement

  Retrospective up to 6 months after study completion

Interventions

Noninvasive Hemodynamic Measurement System DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with congestive heart failure and admitted to the hospital with a diagnosis of acute decompensated heart failure (ADHF).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rodin Scientific LLC: lead
• University of Split, School of Medicine: collaborator

Study Sites (2)

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

University Hospital of Split

Split, 21 000, Croatia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Elena Allen, PhD

  Rodin Scientific

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 24, 2018
• Study Start: June 9, 2018
• Primary Completion: June 24, 2018
• Study Completion: July 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CR (1)