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

Mayo Clinic1 site in 1 country15 target enrollmentJanuary 30, 2020

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Mayo Clinic
Enrollment: 15
Locations: 1
Primary Endpoint: Change in red blood cell volume
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 30, 2020

End Date

December 19, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Wayne L. Miller, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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