Safety of HMA-CD20 in Patients With HFrEF

NCT03332888 | Unknown Phase 2

• 1 other identifier: ICFEr-RITU2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Incidence of Rituximab Emergent Cardiovascular Adverse Events

  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.

  6 months

Study Arms (1)

Interventional Group

EXPERIMENTAL

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.

Drug: Rituximab

Interventions

Rituximab DRUG

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

Interventional Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women (women not pregnant neither in lactation period) between ≥ 40 to 60 years-old.
• Diagnosis of HFrEF and functional class III-IV.
• EF ≤ 40% evaluated by MRI and or transthoracic echocardiography, with validity of twelve months.
• Inadequate response to standard treatment.
• Urgent medical attention or hospitalization due to worsening of HF or MI in the last 12 months.
• Diagnosis of ischemic or non ischemic dilated cardiomyopathy.
• Life expectancy of at least six months, in investigator opinion.
• Participants should sign an (informed consent form) ICF form personally.

You may not qualify if:

• Severe primary valvular cardiopathy or valvular prosthesis (mechanical or bio-valve).
• History of heart transplant surgery, cardiomyoplasty, left ventricular reduction surgery, valvuloplasty, implantation of a ventricle assist device (VAD) and surgical cardiac congenital defect correction.
• Uncontrolled atrial fibrillation (HR \> 100 bpm), atrial flutter, sustained atrial fibrillation and / or significant arrhythmias such as sustained or unsustained ventricular tachychardia, bigeminy or trigeminy evidenced by Holter during the prescreening period.
• Implantable cardioverter defibrillator (ICD) within the last three months.
• Acute coronary syndromes that required pharmacological or mechanical reperfusion or medical treatment, within 30 days before selection.
• Percutaneous coronary intervention within 30 days prior to selection.
• Treatment with inotropic agents (dobutamine, milrinone, levosimendan), I.V. diuretics or vasodilators within 30 days of selection.
• Pregnant women or breast feeding period without adequate prenatal care.
• Untreated thyroid disease.
• Patients with GFR \<30mL/min based on the cockcroft-gualt formula
• Rapidly progressive glomerulonephritis, seizures or psychosis, progressive neuropathy or myopathy.
• Hemoglobin: \< 8.5 mg/dL.
• WBC count less than 5000/mm3
• Platelets: \<100,000/mm, AST or ALT \>2.5 × upper limit of normal (ULN) unless related to primary disease.
• Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody).

Sponsors & Collaborators

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

Related Publications (1)

• Sanchez-Trujillo L, Jerjes-Sanchez C, Rodriguez D, Panneflek J, Ortiz-Ledesma C, Garcia-Rivas G, Torre-Amione G. Phase II clinical trial testing the safety of a humanised monoclonal antibody anti-CD20 in patients with heart failure with reduced ejection fraction, ICFEr-RITU2: study protocol. BMJ Open. 2019 Mar 27;9(3):e022826. doi: 10.1136/bmjopen-2018-022826.

  PMID: 30918029 DERIVED

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Carlos Jerjes Sanchez Diaz, MD

CONTACT

+518188880464; carlos.jerjes@udicem.org

Luis Adolfo Sanchez-Trujillo, MD

CONTACT

+518188880464; alfalui02@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2021
• Primary Completion: April 16, 2021
• Study Completion: July 15, 2021
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share