Last reviewed · How we verify
NCT03332888: ICFEr-RITU2
Safety of HMA-CD20 in Patients With HFrEF
Phase 2 trial testing Rituximab in Heart Failure With Reduced Ejection Fraction in 10 participants. Status unknown.
16 April 2021
Quick facts
| Lead sponsor | Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 January 2021 |
| Primary completion | 16 April 2021 |
| Estimated completion | 15 July 2021 |
Drugs / interventions tested
- Rituximab — full drug profile →
Conditions studied
- Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →
Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Who can join
Adults 40 to 60, any sex, with Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
What Is the Role of the Inflammation in the Pathogenesis of Heart Failure?
Castillo EC, Vázquez-Garza E, Yee-Trejo D, García-Rivas G, et al · · 2020 · cited 56× · PMID 32910299 · DOI 10.1007/s11886-020-01382-2 -
The why and how of adaptive immune responses in ischemic cardiovascular disease.
Mallat Z, Binder CJ. · · 2022 · cited 48× · PMID 36382200 · DOI 10.1038/s44161-022-00049-1 -
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.
Sánchez-Trujillo L, Jerjes-Sanchez C, Rodriguez D, Panneflek J, et al · · 2019 · cited 14× · PMID 30918029 · DOI 10.1136/bmjopen-2018-022826 -
Immunomodulatory Treatment Strategies Targeting B Cells for Heart Failure.
Zhang X, Sun Y, Wang N, Zhang Y, et al · · 2022 · cited 6× · PMID 35350762 · DOI 10.3389/fphar.2022.854592
Verify or expand the search:
- PubMed search for NCT03332888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rituximab
Trials testing the same drug.
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
- NCT06965114 — Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia · Phase 1, PHASE2 · recruiting
- NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
Other recruiting trials for Heart Failure With Reduced Ejection Fraction
Currently open trials in the same condition.
- NCT07465653 — A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction · Phase 1 · recruiting
- NCT07465679 — A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treat · active not recruiting
- NCT07275931 — Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study · NA · recruiting
- NCT06942221 — Digital Solutions in Heart Therapy (DIGNITY) · NA · recruiting
- NCT07087613 — Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · recruiting
Other Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud trials
Trials by the same sponsor.
- NCT03634189 — Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C · Phase 1 · unknown
- NCT03432663 — Time-dependent Amiodarone Treatment in Atrial Fibrillation · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03332888 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
- Last refreshed: 5 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03332888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing