BVA-100 for Acute Decompensated Heart Failure (ADHF)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Boston Healthcare System, Boston, MA
Acute Decompensated Heart Failure (ADHF)+1 More
BVA-100 - DiagnosticTest
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Acute Decompensated Heart Failure (ADHF)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acute Decompensated Heart Failure (ADHF)

Study Objectives

This trial is evaluating whether BVA-100 will improve 1 primary outcome and 4 secondary outcomes in patients with Acute Decompensated Heart Failure (ADHF). Measurement will happen over the course of Approximately 2 weeks.

30 days post discharge
Quantitative assessment of event-based outcome metrics
Approximately 2 weeks
Quantitative assessment of continuous outcome metrics: natriuretic peptide
Quantitative assessment of continuous outcome metrics: net fluid balance
Quantitative assessment of continuous outcome metrics: weight
Quantitative assessment of progress to euvolemic target for both subjects and controls

Trial Safety

Safety Progress

1 of 3

Other trials for Acute Decompensated Heart Failure (ADHF)

Trial Design

2 Treatment Groups

BVA-guided treatment arm
1 of 2
Standard care group
1 of 2
Experimental Treatment

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. BVA-100 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

BVA-guided treatment arm
DiagnosticTest
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
DiagnosticTest
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days post discharge
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days post discharge for reporting.

Closest Location

VA Boston Healthcare System - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Can acute decompensated heart failure (adhf) be cured?

"Acute decompensated heart failure is not truly curable, due to the high prevalence of underlying comorbidities in this population. Only half the patients experienced an improved left ventricular systolic function." - Anonymous Online Contributor

Unverified Answer

How many people get acute decompensated heart failure (adhf) a year in the United States?

"[An estimated 1.5 million people (1%) are hospitalized each year for heart failure in the United States. (http://www.nchs.ssf.tn/datacenter_2/hf_stories_table/story.cfm?chr=2012&pid=817&tab=d.m.chr)]. A disproportionate number of these heart failure patients would be labeled with "not hospitalized" by the definition and indicators of heart failure." - Anonymous Online Contributor

Unverified Answer

What are the signs of acute decompensated heart failure (adhf)?

"The primary finding in patients with acute decompensated heart failure is dyspnea. New-onset congestive heart failure, pulmonary edema, pleural effusions, hypotension, hepatomegaly, jugular venous distension and oliguria are also commonly seen. Furthermore, patients are often found to have anemia and high cholesterol levels." - Anonymous Online Contributor

Unverified Answer

What causes acute decompensated heart failure (adhf)?

"Patients are admitted to the hospital for reasons other than ADHF during a median stay of 8 days. Heart failure exacerbations precede ADHF by up to 30 days, and patients may be hospitalized only for worsening symptoms but still have signs of heart failure. A simple protocol to identify possible causes of ADHF could save hospital admissions, admissions, and resources." - Anonymous Online Contributor

Unverified Answer

What is acute decompensated heart failure (adhf)?

"ADHF is a debilitating illness in which symptoms and signs are rapid and worsening. It is commonly found in patients with heart failure, and is associated with multiple organ system failure that results in hospital admission and a significant burden on health care resources. There continue to be discrepancies in diagnostic criteria and definitions, which adds to the confusion and difficulty in reporting ADHF." - Anonymous Online Contributor

Unverified Answer

What are common treatments for acute decompensated heart failure (adhf)?

"While many treatments are used, there are limited data to evaluate patient outcomes across treatments. Although the vast majority of providers use ACEI and ARB, evidence supporting the use of ARBs in patients with mild-to-moderate heart failure remains insufficient." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of acute decompensated heart failure (adhf)?

"Chronic heart failure is the most common cause of heart failure in patients undergoing evaluation for the diagnosis of acute decompensated heart failure, followed by valvular heart disease and nonischemic cardiomyopathy. Clinicians should take into account any valvular or nonischemic cardiomyopathy when diagnosing acute decompensated heart failure." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving bva-100?

"There is an abundance of available evidence supporting the use of bva-100 for the treatment of heart failure. A significant percentage of clinical trials involve bva-100, particularly for the treatment of advanced heart failure. Because of these available clinical trials and clinical practice, there should be a greater awareness of bva-100 and its role in the current literature on heart failure." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for acute decompensated heart failure (adhf)?

"There were few differences between patients with stable or unstable CHF who received CHF-specific CHF medications regarding whether they would participate in a CHF clinical trial, and these differences were small. Therefore, patients with worsening CHF were no more likely to enroll in a CHF clinical trial than patients with stable or unstable CHF. Patients with worsening CHF were less likely to receive a new treatment agent than patients with stable or unstable CHF. Patients who were less likely to be prescribed a new medication were also more likely to enroll in a clinical trial than patients who were not less likely to be prescribed a new medication." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in bva-100 for therapeutic use?

"With further study, use of BVA-100 will evolve beyond the current indications of congestive heart failure with reduced ejection fraction (HFrEF) and ischaemic heart disease (IHD). BVA-100 is an invaluable tool for therapy of HF." - Anonymous Online Contributor

Unverified Answer

Is bva-100 typically used in combination with any other treatments?

"Results from a recent paper suggests that BVA-100 is commonly used in combination with other therapies. Despite the common practice of using BVA-100 in combination with methotrexate or MMF, no clinical evidence supports using BVA-100 in combination with MMF rather than BVA-100 alone. Clinical studies of BVA-100 and MMF may be more informative and enable the development of consensus recommendations based on the best available evidence for use of these treatments for patients with SSc." - Anonymous Online Contributor

Unverified Answer

How serious can acute decompensated heart failure (adhf) be?

"ADHF in people admitted to the hospital for evaluation of acute decompensated heart failure should be considered a life-threatening condition with short-term mortality close to 25% and in-hospital mortality of about 10%. Survival after discharge is similar to previous reports." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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