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

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Diagnostic Test: BVA-100

• Registration Number: NCT04855097
• Lead Sponsor: Daxor Corporation

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.

Detailed Description

Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases in the United States. High rates of rehospitalization and mortality and treatment costs have persisted for decades despite advances in care. Clinical guidelines recommend assessment of blood volume and clinical management to euvolemia or normal blood volume, but standard methods of diagnosing blood volume status have been shown to be unreliable. Blood Volume Analysis (Daxor BVA-100) is based on the gold standard indicator dilution technique. BVA has been used to quantify otherwise undiagnosed blood volume derangements and guide treatment in heart failure and other indications. Also, retrospective analyses have shown that care of heart failure patients guided by BVA is associated with improved rates of rehospitalization and mortality.

The proposed study is a prospective, two-center, parallel design, interventional, single-blinded pilot study of the potential for BVA to positively impact the treatment decisions of ADHF clinicians.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age > 18 years. In accordance with the Inclusion Across the Lifespan policy, Children will be excluded from the proposed study. ADHF is a condition that rarely affects children and Daxor's BVA-100 lack the reference norms for pediatric use.
2. Admission to the hospital with a primary diagnosis of ADHF.
3. Able and willing to provide informed written consent.

Exclusion Criteria

1. Evidence of acute coronary syndrome or myocardial infarction during qualifying ADHF hospitalization.

2. Evidence of hypertensive crisis or acute valvular regurgitation.

3. The following has occurred within the last 3 months or is planned within the following 3 months:

   1. Revascularization procedure.
   2. Placement on cardiac transplantation list.
   3. Other major cardiac surgery or other surgery.

4. Planned intermittent or continuous intravenous positive inotropic therapy.

5. Severe chronic kidney disease (eGFR<15 ml/min).

6. Psycho-social factors that interfere with ability to adhere to study procedures (severe dementia, active substance abuse, poorly controlled psychiatric illnesses).

7. Pregnant women or nursing mothers.

8. Women of childbearing potential not using adequate birth control methods.

9. Known hypersensitivity to iodine or eggs.

10. Participation in another heart failure investigational treatment protocol currently or <30 days prior to enrollment.

11. Evidence of active bleeding or active hemolysis.

12. Hemoglobin measured below 7 g/dl or hematocrit measured below 21%.

13. Patient has received a heart transplant and/or currently treated with mechanical circulatory support.

14. Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVA-guided treatment arm	BVA-100	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.
Standard care group	BVA-100	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.

Primary Outcome Measures

Name	Time	Method
Quantitative assessment of progress to euvolemic target for both subjects and controls	Approximately 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of event-based outcome metrics	30 days post discharge	30-day readmission and mortality outcomes will be quantified for both cohorts.
Quantitative assessment of continuous outcome metrics: weight	Approximately 2 weeks	Measure and compare changes to body weight in kilogram
Quantitative assessment of continuous outcome metrics: natriuretic peptide	Approximately 2 weeks	Measure and compare changes to natriuretic peptide in pg/mL
Quantitative assessment of continuous outcome metrics: net fluid balance	Approximately 2 weeks	Measure and compare changes to net fluid balance in mL

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States