ior ®EPOCIM as a cardioprotective agent in the surgery of rheumatic valvular disease.

Evaluation of the effect and safety of recombinant human erythropoietin (ior ®EPOCIM ) as a cardioprotective agent in the surgery of rheumatic valvular disease.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000165

Enrollment

Registered

2013-08-26

Start date

2013-08-21

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic valvular disease

Interventions

Study group (ior ® EPOCIM 10 000 IU): 100 IU/Kg body weight, single dose, administered 24 hours before surgery by subcutaneous route. Control group (Placebo. The same composition of ior ® EPOCIM 10 00

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who require replacement or surgical valve plasty by insufficiency or mitral or aortic stenosis caused by rheumatic fever. 2. Patients with age = 18 years and = 65 years. 3. Patients who have signed the informed consent model. 4. Patients with figures of hemoglobin = 13 g/dL.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled arterial hypertension. 2. Patients with insulin-dependent diabetes mellitus. 3. Patients with a known risk or a history of venous or arterial thromboembolic disease. 4. Patients with a known history of renal failure. 5. History of cerebrovascular disease. 6. Oncological diseases. 7. Patients with known hypersensitivity to products derived from upper cells or human albumin. 8. Pregnancy or breastfeeding. 9. Need to replace 2 or more valves or other types of cardiovascular surgery.

Design outcomes

Secondary

Measure	Time frame
The effect-related. Functional class (NYHA) (Physical examination: Grade I, Grade II, Grade III, Grade IV).Measurement time: at baseline, 72 hours after the intervention, 7 days, to the 1st month, at 3, 6 and 12 months. Ventricular ejection fraction (FEV, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Fraction of shortening (FAC, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Global contractility (ECO report. It will be evaluated as: Preserved or altered). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Segmental contractility (ECO report. It will be evaluated as: Normal, hypokinesia, Akinesia, dyskinesia of one or more segments). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-systolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-diastolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Safety-related. Occurrence of any AE (Yes, No). Measurement time: 12 months after administration of the product. Description of the AE (type of AE presented). Measurement time: 12 months after administration of the product. Duration of the AE (the difference in dates between the start and the completion of the event). Measurement time: 12 months after administration of the product. Intensity of the AE (1.Mild, 2.Moderate, 3.Severe). Measurement time: 12 months after administration of the product. Consequence of the AE (Serious, Not serious).Measurement time: 12 months after administration of the product. Result of the AE	—

Measure

Time frame

The effect-related. Functional class (NYHA) (Physical examination: Grade I, Grade II, Grade III, Grade IV).Measurement time: at baseline, 72 hours after the intervention, 7 days, to the 1st month, at 3, 6 and 12 months. Ventricular ejection fraction (FEV, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Fraction of shortening (FAC, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Global contractility (ECO report. It will be evaluated as: Preserved or altered). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Segmental contractility (ECO report. It will be evaluated as: Normal, hypokinesia, Akinesia, dyskinesia of one or more segments). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-systolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-diastolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Safety-related. Occurrence of any AE (Yes, No). Measurement time: 12 months after administration of the product. Description of the AE (type of AE presented). Measurement time: 12 months after administration of the product. Duration of the AE (the difference in dates between the start and the completion of the event). Measurement time: 12 months after administration of the product. Intensity of the AE (1.Mild, 2.Moderate, 3.Severe). Measurement time: 12 months after administration of the product. Consequence of the AE (Serious, Not serious).Measurement time: 12 months after administration of the product. Result of the AE

—

Primary

Measure	Time frame
Postsurgical myocardial damage (cardiac biomarker (troponin T) in ng/mL). Measurement time: 48 hours previous to the intervention, 1st and 2nd postoperative day every 12 hours. Daily in Day 3, 5, and 7 of the postoperative.	—

Countries

Cuba

Contacts

Public ContactOrestes Santos Morales

CIMAB

orestesm@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026