Status:
COMPLETED
Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Lead Sponsor:
Daxor Corporation
Collaborating Sponsors:
VA Boston Healthcare System
Minneapolis Veterans Affairs Medical Center
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 an...
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...
Eligibility Criteria
Inclusion
- 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.
- Admission to the hospital with a primary diagnosis of ADHF.
- Able and willing to provide informed written consent.
Exclusion
- 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%.
- Patient has received a heart transplant and/or currently treated with mechanical circulatory support.
- Patients implanted with invasive hemodynamic monitors (i.e. CardioMEMS).
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04855097
Start Date
May 1 2022
End Date
December 31 2022
Last Update
September 29 2023
Active Locations (1)
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1
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130