Acute Decompensated Heart Failure Clinical Trial
Official title:
Evaluation of Blood Volume Analysis- Guided Management of Decompensated Heart Failure
Verified date | September 2023 |
Source | Daxor Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | VA Boston Healthcare System | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Daxor Corporation | Minneapolis Veterans Affairs Medical Center, VA Boston Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quantitative assessment of event-based outcome metrics | 30-day readmission and mortality outcomes will be quantified for both cohorts. | 30 days post discharge | |
Secondary | Quantitative assessment of continuous outcome metrics: weight | Measure and compare changes to body weight in kilogram | Approximately 2 weeks | |
Secondary | Quantitative assessment of continuous outcome metrics: net fluid balance | Measure and compare changes to net fluid balance in mL | Approximately 2 weeks | |
Secondary | Quantitative assessment of continuous outcome metrics: natriuretic peptide | Measure and compare changes to natriuretic peptide in pg/mL | Approximately 2 weeks |
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