Clinical trial NCT04855097: Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Official title: Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Heart Failure
Blood Volume
Lead sponsor: Daxor Corporation
Sponsor class: INDUSTRY
Collaborators: name: VA Boston Healthcare System
name: Minneapolis Veterans Affairs Medical Center
First posted: 2021-04-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two-center, parallel design, interventional, single-blinded pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Quantitative assessment of progress to euvolemic target for both subjects and controls
timeFrame: Approximately 2 weeks
Secondary outcomes:
measure: Quantitative assessment of event-based outcome metrics
timeFrame: 30 days post discharge
measure: Quantitative assessment of continuous outcome metrics: weight
timeFrame: Approximately 2 weeks
measure: Quantitative assessment of continuous outcome metrics: net fluid balance
timeFrame: Approximately 2 weeks
measure: Quantitative assessment of continuous outcome metrics: natriuretic peptide
timeFrame: Approximately 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: Boston VA Healthcare System
name: Jacob Joseph
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Bradley Bart
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Orly Vardeny
role: PRINCIPAL_INVESTIGATOR
References: