The Cardio-protective Effect of Cardiomyopeptidin on Myocardial Injury in ICU Patients With Non-organic Heart Disease: a Prospective, Single-blind, Randomized Controlled Pilot Study

NCT06117046 | Completed Phase 4

• 1 other identifier: NFEC-2023-060
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

The study was a single-center, randomized controlled pilot study. To explore the cardioprotective effect of cardiopeptidin on non-heart disease patients with severe cardiac injury by comparing whether cardiopeptidin was used.

Conditions

Myocardial Injury; ICU

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac events

  major adverse cardiac events

  On the day of enrollment, until 28 days.

Secondary Outcomes (13)

• 28-day all-cause mortality

  28-day

• 90-day all-cause mortality

  90-day

• Cardiac adverse events

  In hospital, until the patient is discharged.

• LVEF

  On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

• APACHE II

  On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

Study Arms (2)

Cardiopeptidin

EXPERIMENTAL

Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days

Drug: Cardiopeptidin

50 ml of normal saline intravenous infusion

PLACEBO COMPARATOR

50 ml of normal saline intravenous infusion.

Drug: 50 ml of normal saline intravenous infusion

Interventions

Cardiopeptidin DRUG

Cardiopeptidin was administered intravenously once a day with cardiopeptidin for 3 days.The dosing regimen follows the recommended dosage of 1 mg/kg/day as outlined in the product manual, with doses calculated based on the ideal body weight.

Cardiopeptidin

50 ml of normal saline intravenous infusion DRUG

50 ml of normal saline intravenous infusion

50 ml of normal saline intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• The high-sensitive troponin T index was higher than the normal value during ICU hospitalization
• Obtain the informed consent of the subject or legal agent

You may not qualify if:

• Patients who are expected to die within 48 hours of ICU admission
• previous diagnosis of acute coronary syndrome, chronic cardiomyopathy, pulmonary heart disease, acute myocarditis, pericardial tamponade and other diseases that have been confirmed to cause myocardial injury
• cardiopulmonary resuscitation and/or electrical defibrillation before admission
• patients with acute ischemic stroke
• patients with stage 5 chronic kidney disease
• during pregnancy or breastfeeding

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern medical university Nanfang hospital

Guangzhou, 510515, China

Location

Study Officials

• zhenhua zeng

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: November 3, 2023
• Study Start: February 27, 2023
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)