Hemodynamic Assessment in Acute Decompensated Heart Failure

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT03535909
• Lead Sponsor: Rodin Scientific LLC

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.

Study Timeline

• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-06-09
• Primary Completion: 2018-06-24
• Study Completion: 2018-07-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Estimated Changes in Stroke Volume	Retrospective up to 6 months after study completion	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of Central Venous Pressure Measurement	Retrospective up to 6 months after study completion	Comparison of Central Venous Pressure Measurement (units of cmH2O) from the optical measurement system with paired Central Venous Pressure Measurement (cmH2O) from the reference device. Accuracy will be measured in percentage error and Bland-Altman limits of agreement.

Trial Locations

Locations (2)

New Mexico Heart Institute; 🇺🇸 Albuquerque, New Mexico, United States

University Hospital of Split; 🇭🇷 Split, Croatia