Daxor - Blood Volume Analysis

NCT04111185 | Completed Results FDA Device

• 1 other identifier: Pro00102851
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

Conditions

Heart Failure; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Whole Blood Volume

  Baseline, and upon discharge (up to day 18)

Secondary Outcomes (7)

• Change in Congestion Metrics as Measured With a Clinical Congestion Score (Pulmonary Edema, Jugular Venous Pressure, Lower Extremity Edema and PND)

  Baseline, day 1, day 2, day 3 and discharge (up to day 18)

• Change in Mean NTpro-BNP Concentration (in pg/mL)

  Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

• Change in Weight (in kg)

  Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

• Change in Renal Function as Measured by Creatinine (mg/dL)

  Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to discharge

• Change in Renal Function as Measured by Blood Urea Nitrogen (mg/dL)

  Baseline, day 1, day 2, day 3 and discharge (up to day 18)

Study Arms (2)

Receive Blood Volume Analysis Guided Treatment

EXPERIMENTAL

The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.

Device: Receive Blood Volume Analysis Guided Treatment

Receive Standard of Care Treatment

NO INTERVENTION

The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.

Interventions

Receive Blood Volume Analysis Guided Treatment DEVICE

The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis

Also known as: Daxor BVA-100

Receive Blood Volume Analysis Guided Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina

You may not qualify if:

• Age \< 18 years
• Ongoing pregnancy
• Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days
• Post heart transplantation or ongoing mechanical circulatory support
• Progressive cardiogenic shock
• Patients with Ventricular Assist Devices
• End stage renal disease

Sponsors & Collaborators

• Duke University: lead
• Daxor Corporation: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Marat Fudim, MD, MHS
• Organization: Duke University

marat.fudim@duke.edu

919-684-1284

Study Officials

• G. Michael Felker, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 1, 2019
• Study Start: July 16, 2020
• Primary Completion: July 15, 2021
• Study Completion: September 23, 2021
• Last Updated: June 28, 2023
• Results First Posted: September 29, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)