Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure

NCT04855097 | Completed FDA Device

• 1 other identifier: BVA for inpatient HF
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Diuretic therapy is first-line treatment for acute decompensated heart failure. However, accurate assessment and management of patient blood volume is challenged by the limitations of physical exam and surrogate markers for blood volume. The study primary objective is to determine if goal-directed care as quantified by direct Blood Volume Analysis (Daxor BVA-100™) in addition to usual care results in more appropriate treatment and consistent achievement of euvolemia.

Conditions

Acute Decompensated Heart Failure

Keywords

Heart Failure; Blood Volume

Outcome Measures

Primary Outcomes (1)

• Quantitative assessment of progress to euvolemic target for both subjects and controls

  Accurately quantify levels and changes to blood volume and red blood cell volume in ADHF inpatients during inpatient stay, and use this data to guide diuretic therapy in the treatment arm.

  Approximately 2 weeks

Secondary Outcomes (4)

• Quantitative assessment of event-based outcome metrics

  30 days post discharge

• Quantitative assessment of continuous outcome metrics: weight

  Approximately 2 weeks

• Quantitative assessment of continuous outcome metrics: net fluid balance

  Approximately 2 weeks

• Quantitative assessment of continuous outcome metrics: natriuretic peptide

  Approximately 2 weeks

Study Arms (2)

Standard care group

EXPERIMENTAL

Blood Volume Analysis will be performed at admission, during inpatient stay if warranted, and prior to hospital discharge. Treating physicians will be blinded to the results and will choose between a low-moderate and high diuretic dose based on usual care clinical assessment of volume status.

Diagnostic Test: BVA-100

BVA-guided treatment arm

EXPERIMENTAL

Blood Volume Analysis will be performed at admission, during inpatient stay if warranted, and prior to hospital discharge. Treating physicians will receive the results and will choose between a low-moderate and high diuretic dose based on measured volume status.

Diagnostic Test: BVA-100

Interventions

BVA-100 DIAGNOSTIC_TEST

The BVA-100 is a medical device that calculates human blood volume using the method of tracer dilution. The device utilizes a tracer of human serum albumin tagged with iodine-131 to measure injected intravascularly and a series of timed blood draws. The amount of tracer in each blood draw is used to calculate the unknown blood volume. Data inputs come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and tracer transudation rate are reported, with statistics showing the quality of the results.

BVA-guided treatment arm; Standard care group

Eligibility Criteria

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

You may qualify if:

• Admission to the hospital with a primary diagnosis of ADHF.
• Able and willing to provide informed written consent.

You may not qualify if:

• Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.
• Evidence of hypertensive crisis or acute valvular regurgitation.
• The following has occurred within the last 3 months or is planned within the following 3 months:
• Revascularization procedure.
• Placement on cardiac transplantation list.
• Other major cardiac surgery or other surgery.
• Planned intermittent or continuous intravenous positive inotropic therapy.
• Severe chronic kidney disease (eGFR\<15 ml/min).
• Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).
• Pregnant women or nursing mothers.
• Women of childbearing potential not using adequate birth control methods.
• Known hypersensitivity to iodine or eggs.
• Participation in another heart failure investigational treatment protocol currently or \<30 days prior to enrollment.
• Evidence of active bleeding or active hemolysis.
• Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.

Sponsors & Collaborators

• Daxor Corporation: lead
• VA Boston Healthcare System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jacob Joseph

  Boston VA Healthcare System

  PRINCIPAL INVESTIGATOR

• Bradley Bart

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

• Orly Vardeny

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and treating physicians will have no access to the BVA data in the Standard Care arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, two-center, parallel design, interventional, single-blinded pilot study

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will become available as collected throughout the study, and will be available for 18months prior to the completion of the study, for analysis.

Locations

US (1)