Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial

• Sponsor: Nanfang Hospital, Southern Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06117046
• Collaborator: (none)
• Enrollment: 234
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 26.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury; ICU	Drug: Cardiopeptides	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Cardioprotective Effects of Cardiopeptides for Injection in Patients With Non-severe Cardiac Disease: a Single-center Randomized Controlled Trial
• Actual Study Start Date: Feb 27, 2023
• Anticipated Primary Completion Date: Nov 25, 2023
• Anticipated Study Completion Date: Nov 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiopeptides Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days	Drug: Cardiopeptides; Cardiopeptide was administered intravenously once a day with 60mg of cardiopeptide for 3 days
No Intervention: Empety

Outcome Measures

Primary Outcome Measures

1. Hypersensitive troponin T [On the day of enrollment, 1/3/6/13 days after enrollment，up to two weeks]

   Hypersensitive troponin T

Secondary Outcome Measures

1. Cardiac adverse events [In hospital, until the patient is discharged.]

   Cardiac adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern medical university Nanfang hospital	Guangzhou		China	510515

Sponsors and Collaborators

• Nanfang Hospital, Southern Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nanfang Hospital, Southern Medical University
• ClinicalTrials.gov Identifier: NCT06117046
• Other Study ID Numbers: NFEC-2023-060
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Nov 3, 2023