Heart Failure Clinical Trial

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Summary

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

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Full Description

The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal.

BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

6

Study ID:

NCT04241718

Recruitment Status:

Terminated

Sponsor:

Nuwellis, Inc.

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There is 1 Location for this study

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Midwest Cardiovascular Institute
Naperville Illinois, 60540, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

6

Study ID:

NCT04241718

Recruitment Status:

Terminated

Sponsor:


Nuwellis, Inc.

How clear is this clinincal trial information?

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