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OpenTrials
Completed

NCT Number: NCT04156854

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitated Blood Volume Analysis

Diagnostic Test

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

Primary outcomes

  1. Change in total blood volume

    Time frame: Baseline, 1 month, 3 month, and 6 month

    Measured in milliliters

  2. Change in red blood cell volume

    Time frame: Baseline, 1 month, 3 month, and 6 month

    Measured in milliliters

  3. Change in plasma volume

    Time frame: Baseline, 1 month, 3 month, and 6 month

    Measured in milliliters

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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