Safety of HMA-CD20 in Patients With HFrEF

Phase 2

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: Rituximab

• Registration Number: NCT03332888
• Lead Sponsor: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05
• Study Start: 2021-01-01
• Primary Completion: 2021-04-16
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Group	Rituximab	For this trial, HMA-CD20 will be given as an intravenous infusion of 1000 mg I.V twice in a month separating them by fourteen days starting at the baseline visit. The dose for both HMA-CD20 dosages willbe identical at the screening visit after the participant's eligibility has been established, and it will remain thesame for both infusions. The standard dose for HMA-CD20 is 1,000 mg per intravenous infusion on day 1 and day 15.

Primary Outcome Measures

Name	Time	Method
Incidence of Rituximab Emergent Cardiovascular Adverse Events	6 months	The investigators analyze the safety of rituximab based on the occurrence of cardiovascular adverse events such as arrhythmia, worsening of symptoms and acute coronary syndromes.