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Safety of HMA-CD20 in Patients With HFrEF

NCT03332888 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-08-05

No results posted yet for this study

Summary

The study is a phase II single-centered, single group, prospective clinical trial to evaluate the safety of HMA-CD20 doses among stable patients with class III/IV according to the NYHA classification with HFrEF receiving standard of care therapy. The index qualifying HFrEF must have EF \< 40% based on echocardiographic or cardiac MRI techniques, heart failure class III/IV according to the NYHA classification,aged 40-60 years, being diagnosed less than 12 months before enrollment of study, following the standard heart failure treatment regimen.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

Rituximab

Rituximab will be studied in patients with HFrEF, and verify the patients safety.

Sponsors & Collaborators

  • Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-04-16
Completion
2021-07-15

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Entities

Drugs

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 NCT03332888 on ClinicalTrials.gov