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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up30 days post discharge
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing whether using a machine to directly measure blood volume in addition to usual care results in more appropriate treatment and better patient outcomes.
Eligible Conditions
- Acute Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitative assessment of progress to euvolemic target for both subjects and controls
Secondary outcome measures
Quantitative assessment of continuous outcome metrics: natriuretic peptide
Quantitative assessment of continuous outcome metrics: net fluid balance
Quantitative assessment of continuous outcome metrics: weight
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard care groupExperimental Treatment1 Intervention
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.
Group II: BVA-guided treatment armExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BVA-100
2020
N/A
~90
Find a Location
Who is running the clinical trial?
Daxor CorporationLead Sponsor
11 Previous Clinical Trials
235 Total Patients Enrolled
6 Trials studying Heart Failure
124 Patients Enrolled for Heart Failure
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,478 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
69 Previous Clinical Trials
14,637 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently accepting participants for this experiment?
"According to clinicaltrials.gov, this trial is currently enlisting participants. The study was initiated on May 1st 2022 and modified in late July of the same year."
Answered by AI
How many participants are being recruited for this experiment?
"Affirmative, according to the information available on clinicaltrials.gov this medical trial is currently enlisting participants. This study was initially posted in May 1st 2022 and received a recent update at July 25th 2022; 32 research subjects need to be recruited from one site location."
Answered by AI
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