Cardiovascular DiseasePANDANCT04444349
Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)
A study testing Coenzyme Q10 and Standard Medical Therapy in people with Cardiovascular Disease, run by Nanjing Medical University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Coenzyme Q10 and Standard Medical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 1 Feb 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women
- Who receive cardiovascular surgery
- Agree to participate in the surgery and sign the informed consent form
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality
SI-CHONG Qian, MD, drqsc1990a@163.com
HONG-JIA Zhang, cwwcsxzr@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Hong-hua Yue, MD, yuecqmu@163.com
Zhong Wu, MD, wuzhong71@scu.edu.cn
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
YING-YUAN Zhang, MD, 13662378847@139.com
Ying-yuan Zhang, MD, 8613662378847, 13662378847@139.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Hong Liu, MD, 18801281613, dr.hongliu@foxmail.com
Hong MD, MD, dr.hongliu@foxmail.com
About this study
Official title: Protective Effect of Coenzyme Q10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiac and Aortic Surgery (PANDA V): a Randomized Controlled Trial
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.
- Conditions
- Cardiovascular Disease
- Being tested
- Coenzyme Q10, Standard Medical Therapy
- Keywords
- inflammatory response
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called ubiquinone
Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.
Standard Medical TherapyDietary supplement
Patients only received standard medical therapy without CoQ10.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 group | Experimental | Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day). Receives: Drug: Coenzyme Q10 |
| Control | Sham comparator | patients only receive standard medical therapy. Receives: Dietary Supplement: Standard Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Inflammatory and endothelial blood work biomarkers
Measured: Change from baseline of CRP in mg/L at 5 days after surgery.
Secondary outcomes (1)
Interleukin-6
Inflammatory and endothelial blood work biomarkers
Measured: Change from baseline of IL-6 in pg/mL at 5 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444349
- Sponsor's protocol ID
- PANDA V
- Acronym
- PANDA
- Status last verified
- Nov 2024
- First submitted
- 20 Jun 2020
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Coenzyme Q10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiac and Aortic Surgery (PANDA V): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04444349
- Acronym / sponsor ID
- PANDA / PANDA V
- Conditions
- Cardiovascular Disease
- Keywords
- inflammatory response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Beijing Anzhen Hospital, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 group | Experimental | Drug: Coenzyme Q10Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day). |
| Control | Sham comparator | Dietary Supplement: Standard Medical Therapypatients only receive standard medical therapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men and women
- Who receive cardiovascular surgery
- Agree to participate in the surgery and sign the informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: ubiquinoneCoenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation. | Drug | Coenzyme Q10 group |
| Standard Medical TherapyPatients only received standard medical therapy without CoQ10. | Dietary supplement | Control |
Primary outcome
C-reactive protein
Time frame: Change from baseline of CRP in mg/L at 5 days after surgery.
Inflammatory and endothelial blood work biomarkers
1 secondary outcome
Interleukin-6
Time frame: Change from baseline of IL-6 in pg/mL at 5 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 and Standard Medical Therapy in people with Cardiovascular Disease, run by Nanjing Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (8618801281613, dr.hongliu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (time frame: Change from baseline of CRP in mg/L at 5 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.