Hemodynamic Assessment in Acute Decompensated Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Hemodynamic Assessment Throughout Diuretic Treatment in Acute Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535909
• Other study ID #: RS-2018-S01
• Status: Completed
• Start date: June 9, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: March 2019
• Source: Rodin Scientific LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 31, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital of Split	Split
United States	New Mexico Heart Institute	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Rodin Scientific LLC	University of Split, School of Medicine

Countries where clinical trial is conducted

United States,  Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accuracy of Central Venous Pressure Measurement	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.	Retrospective up to 6 months after study completion