Congenital Heart DiseaseNCT01653223
Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
A study testing simvastatin in people with Congenital Heart Disease and Heart Valve Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Heart Valve Disease
- What is being tested?
- simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18-year-old,
- Congenital heart disease(not complex),
- Isolated heart valve disease,
Who cannot join
- Coronary artery disease
- Allergy for statins
- Poor liver function,Hepatitis
- Gestation women and Breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhi-ping Wang, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Cong-zhi Rao, MD, 87333122, raoczh@mail.sysu.edu.cn
Jing-song Ou, MD,PhD
About this study
Official title: A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.
- Conditions
- Congenital Heart Disease, Heart Valve Disease
- Being tested
- simvastatin
- Medical subject headings
- Heart Defects, Congenital, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called simcor
In short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days.
In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | untreated |
| short statin | Experimental | Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 7 days postoperatively. Receives: Drug: simvastatin |
| long statin | Experimental | Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 6 months postoperatively. Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
troponin
The investigator will measure the plasma troponin level in several time points before and after surgery in each patient. This is mainly for the comparason between control and short statin, which has been proved in our previous clinical trial: statin1.
Measured: within the first 7 days after surgery
ejection fraction
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6,12,18 and 24 months after surgery. The ejection fraction will be measured. This is mainly for the comparason between short statin and long statin, which is the major goal in this clinical trial: statin 2.
Measured: within two years
Secondary outcomes (1)
long term survival
Each patient will be followed up and observed survival time.
Measured: within two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-song Ou, Sun Yat-sen University
- Investigators
- Jing-song Ou, MD,PhD, Principal investigator, The Frist Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653223
- Sponsor's protocol ID
- statin2
- Other IDs
- 5010-2012001, 5010-2014002
- Status last verified
- Apr 2023
- First submitted
- 26 Jul 2012
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marques Antunes M, Nunes-Ferreira A, Duarte GS, Gouveia E Melo R, Sucena Rodrigues B, Guerra NC, Nobre A, Pinto FJ, Costa J, Caldeira D. Preoperative statin therapy for adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Jul 22;7(7):CD008493. doi: 10.1002/14651858.CD008493.pub5.
PubMed 39037762
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01653223
- Acronym / sponsor ID
- statin2
- Conditions
- Congenital Heart Disease, Heart Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jul 2012 (estimated)
- 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.
Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –untreated |
| short statin | Experimental | Drug: simvastatinSimvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 7 days postoperatively. |
| long statin | Experimental | Drug: simvastatinSimvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 6 months postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 18-year-old,
- Congenital heart disease(not complex),
- Isolated heart valve disease,
Key exclusion criteria (4 listed)
- Coronary artery disease
- Allergy for statins
- Poor liver function,Hepatitis
- Gestation women and Breast-feeding women
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 |
|---|---|---|
| simvastatinAlso: simcorIn short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days. In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months. | Drug | long statin, short statin |
Primary outcome
troponin
Time frame: within the first 7 days after surgery
The investigator will measure the plasma troponin level in several time points before and after surgery in each patient. This is mainly for the comparason between control and short statin, which has been proved in our previous clinical trial: statin1.
ejection fraction
Time frame: within two years
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6,12,18 and 24 months after surgery. The ejection fraction will be measured. This is mainly for the comparason between short statin and long statin, which is the major goal in this clinical trial: statin 2.
1 secondary outcome
long term survival
Time frame: within two years
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 21 Apr 2023.
- Derived from this study: PubMed 39037762Marques Antunes M, Nunes-Ferreira A, Duarte GS, Gouveia E Melo R, Sucena Rodrigues B, Guerra NC, Nobre A, Pinto FJ, Costa J, Caldeira D. Preoperative statin therapy for adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Jul 22;7(7):CD008493. doi: 10.1002/14651858.CD008493.pub5.
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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.
Zhi-ping Wang, MD, PhD contact
Jing-song Ou, MD,PhD principal investigator
The Frist Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simvastatin in people with Congenital Heart Disease and Heart Valve Disease, run by Sun Yat-sen University at 1 site 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 4 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Jing-song Ou, MD, PhD (8620-87755766 ext. 8238, oujs2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
troponin (time frame: within the first 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653223, which also lists 1 linked publication.
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 21 Apr 2023.