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SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)

NCT04589065 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-27

No results posted yet for this study

Summary

The purpose of this clinical trial is to see if a new device (SCD) is safe and if it can reduce damage to the kidney enough to allow medications to work to improve heart and kidney function for use in patients that have moderate to severe heart failure and is at least in part due to heart failure and it not responding to standard medical therapy. The SCD is a cartridge used with a commercial hemodialysis unit.

Participants will be enrolled in the clinical trial once eligibility is confirmed. In addition to clinical assessments and laboratory testing participants will have surface echocardiograms during the trial. The SCD treatment will take place for 4 hours on day 1, 3, and 5 while on hemodialysis.

Conditions

  • Heart Failure
  • Chronic Systolic Heart Failure
  • Renal Failure
  • Cardiorenal Syndrome

Interventions

DEVICE

Selective Cytopheretic Device

SCD therapy will take place for 4 hours on day 1, 3, and 5 while on hemodialysis treatment. Participants will be continue to be followed until 30 days after the last SCD treatment.

Sponsors & Collaborators

  • Lenar Yessayan

    lead OTHER

Principal Investigators

  • Keith Aaronson, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589065 on ClinicalTrials.gov