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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Injury; ICU
• Intervention / Treatment: Drug: Cardiopeptidin; Drug: 50 ml of normal saline intravenous infusion

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510515
    • Southern medical university Nanfang hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who are expected to die within 48 hours of ICU admission
2. 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
3. cardiopulmonary resuscitation and/or electrical defibrillation before admission
4. patients with acute ischemic stroke
5. patients with stage 5 chronic kidney disease
6. during pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiopeptidin; Cardiopeptidin was administered intravenously once a day with 60mg of cardiopeptide for 3 days	Drug: Cardiopeptidin; 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.
Placebo Comparator: 50 ml of normal saline intravenous infusion; 50 ml of normal saline intravenous infusion.	Drug: 50 ml of normal saline intravenous infusion; 50 ml of normal saline intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiac events	major adverse cardiac events	On the day of enrollment, until 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day all-cause mortality	28-day all-cause mortality	28-day
90-day all-cause mortality	90-day all-cause mortality	90-day
Cardiac adverse events	Cardiac adverse events	In hospital, until the patient is discharged.
LVEF	LVEF	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
APACHE II	APACHE II	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
Hypersensitive troponin T	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
MB	MB	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
NT-Pro BNP	NT-Pro BNP	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
LDH	LDH	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
α-HBDH	α-HBDH	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
CK	CK	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
CKMB	CKMB	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks
Lac	Lac	On the day of enrollment, 1/4/7/14 days after enrollment，up to two weeks

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: zhenhua zeng, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2023-060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No