Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)

Not Applicable

Recruiting

• Conditions: Cardiovascular Disease
• Interventions: Drug: Coenzyme Q10; Dietary Supplement: Standard Medical Therapy

• Registration Number: NCT04444349
• Lead Sponsor: Nanjing Medical University

Brief Summary

Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Study Start: 2021-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Adult men and women
• Who receive cardiovascular surgery
• Agree to participate in the surgery and sign the informed consent form

Exclusion Criteria

• Pregnant or planning on getting pregnant during the study
• Contain a minimum of 2 traits of metabolic syndrome
• Refused to participate in the surgery and refused informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10 group	Coenzyme Q10	Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).
Control	Standard Medical Therapy	patients only receive standard medical therapy.

Primary Outcome Measures

Name	Time	Method
C-reactive protein	Change from baseline of CRP in mg/L at 5 days after surgery.	Inflammatory and endothelial blood work biomarkers

Secondary Outcome Measures

Name	Time	Method
Interleukin-6	Change from baseline of IL-6 in pg/mL at 5 days after surgery.	Inflammatory and endothelial blood work biomarkers

Trial Locations

Locations (4)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China