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Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04156854
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
31
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are trying learn more about how the heart and blood volume interact in subjects with heart failure and how measuring blood volume may help them develop better ways of treating and managing heart failure patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Quantitated Blood Volume Analysis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pathophysiologic and Outcomes Impact of the Relation of Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure - Pathway to More Individualized Therapy
Actual Study Start Date :
Jan 30, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects with heart failure

Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done

Diagnostic Test: Quantitated Blood Volume Analysis
Measurement of total blood volume, composed of red blood cell mass (RBCM) and plasma volume (PV) by administering low dose iodinated I-131 labeled albumin intravenously then taking blood samples at timed increments.
Other Names:
  • BVA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in total blood volume [Baseline, 1 month, 3 month, and 6 month]

      Measured in milliliters

    2. Change in red blood cell volume [Baseline, 1 month, 3 month, and 6 month]

      Measured in milliliters

    3. Change in plasma volume [Baseline, 1 month, 3 month, and 6 month]

      Measured in milliliters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Acute Decompensated Chronic Heart Failure, diagnosed clinically with volume overload by the primary Heart Failure provider or Emergency Department physician and admitted to hospital.

    • New York Hear Association functional class III-IVa with stage C or D Heart Failure with Left Ventricular Ejection Fraction <50%

    • Intended treatment plan with intravenous loop diuretic therapy during hospitalization

    • Meeting none of the Exclusion Criteria

    Exclusion Criteria:

    • Age < 18 years

    • Having received any investigational drug or device within 30 days prior to entry into the study.

    • Clinically unstable patients (e.g. systolic blood pressure < 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).

    • Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.

    • Prior organ transplantation or being on a waiting list for organ transplantation

    • Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).

    • History of blood pressure > 190/115 mmHg or unexplained syncope within the past 3 months.

    • Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months

    • Clinically significant intrinsic renal disease (eGFR <15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries

    • Baseline hemoglobin < 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal

    • History of alcohol abuse within the past 6 months.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Wayne Miller, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Wayne L. Miller, M.D., Ph.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04156854
    Other Study ID Numbers:
    • 19-006517
    First Posted:
    Nov 8, 2019
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Nov 11, 2021