Safety of HMA-CD20 in Patients With HFrEF

Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Study ID
NCT03332888
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Aug 2020
Primary completion
Apr 16, 2021
Completion
Jul 15, 2021

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Group
    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 Measure

Incidence of Rituximab Emergent Cardiovascular Adverse Events [ Time Frame: 6 months ]

Central Contacts

Related Studies