A Feasibility Study on Ultrafiltration and Blood Volume Measurements

  • STATUS
    Recruiting
  • participants needed
    15
  • sponsor
    CHF Solutions
Send
Updated on 16 February 2024
See if I qualify
heart failure
dyspnea
fluid overload
edema
hematocrit
chest x-ray
orthopnea
pleural effusion
ultrafiltration
acute decompensated heart failure
hypervolemia
adhf
pitting edema

Summary

The objective of this feasibility study is to characterize the performance of CHF Solutions' ultrafiltration system, the Aquadex FlexFlow System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). Monitor blood volume changes during UF therapy as a potential mean to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Details
Condition Fluid Overload, Acute Decompensated Heart Failure
Age 18years - 100years
Treatment Aquadex FlexFlow System and BVA-100
Clinical Study IdentifierNCT04241718
SponsorCHF Solutions
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Subject or legally authorized representative is able to provide appropriate consent to participate
Hospitalized for ADHF with fluid overload as indicated by at least two of the
following
Pitting edema 2+ of the lower extremities
Jugular venous distention > 8 cm
Pulmonary edema/pleural effusion on chest x-ray
Paroxysmal nocturnal dyspnea or two- pillow orthopnea
Respiration rate 20 per minute

Exclusion Criteria

Unable or unwillingness to provide informed consent or to comply with study requirements
Subject who is pregnant
Acute coronary syndrome
Known bilateral renal artery stenosis
Serum creatinine > 3.0 mg/dL at the time of presentation
Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
Systolic blood pressure 90 mmHg
Poor or unattainable central access
Has bleeding disorder
Contraindications to systemic anticoagulation
Allergic to iodine, albumin, or iodinated I-131 albumin
Active myocarditis or hypertrophic obstructive cardiomyopathy
Severe uncorrected valvular stenosis
Complex congenital heart disease
Systemic infection
Previous organ transplant
Enrollment in other clinical trials
Life expectancy 6 months
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

heart failure
dyspnea
fluid overload
edema
hematocrit
chest x-ray
orthopnea
pleural effusion
ultrafiltration
acute decompensated heart failure
hypervolemia
adhf
pitting edema

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.