Rheumatic Heart DiseaseNCT01178710
Effect of Simvastatin on Cardiac Function
A study testing Simvastatin in people with Rheumatic Heart Disease and Congenital Heart Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Rheumatic Heart Disease, Congenital Heart Disease, Aneurysm
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cyanotic congenital heart disease
- noncyanotic congenital heart disease with pulmonary hypertension
- Heart valve disease,
- other heart and great artery diseases need heart or great artery surgery
Who cannot join
- Coronary artery disease
- under 10-year-old.
- noncyanotic congenital heart disease without pulmonary hypertension
- poor liver function such AST elevated,Hepatitis
- Gestation women and Breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.
Read the detailed description
Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery.
Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.
- Being tested
- Simvastatin
- Medical subject headings
- Rheumatic Heart Disease, Heart Defects, Congenital, Aneurysm, 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
20 mg per day, start at 5 days before surgery and continue for one year. For some congenital heart diseases which other drugs such as digoxin, antistone, furosemide were prescribed less than half year, simvastatin will be prescribed less than half year.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: Simvastatin |
| untreated | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma troponin T level
The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.
Measured: within the first 7 days after surgery
Secondary outcomes (1)
the index of B ultrasound on heart
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6 and 12 months after surgery. The index of B ultrasound on heart, such as ejection fraction, the diameter of left ventricle, will be measured
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatic 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 151 participants (actual)
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
- NCT01178710
- Sponsor's protocol ID
- statinstudy1
- Status last verified
- Jul 2012
- First submitted
- 9 Aug 2010
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
White CW, Gobel FL, Campeau L, Knatterud GL, Forman SA, Forrester JS, Geller NL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Rosenberg Y, Terrin ML; Post Coronary Artery Bypass Graft Trial Investigators. Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001 Nov 27;104(22):2660-5. doi: 10.1161/hc4701.099730.
PubMed 11723015Ali IS, Buth KJ. Preoperative statin use and outcomes following cardiac surgery. Int J Cardiol. 2005 Aug 3;103(1):12-8. doi: 10.1016/j.ijcard.2004.06.006. Epub 2004 Nov 6.
PubMed 16061117Greer JJ, Kakkar AK, Elrod JW, Watson LJ, Jones SP, Lefer DJ. Low-dose simvastatin improves survival and ventricular function via eNOS in congestive heart failure. Am J Physiol Heart Circ Physiol. 2006 Dec;291(6):H2743-51. doi: 10.1152/ajpheart.00347.2006. Epub 2006 Jul 14.
PubMed 16844920Almansob MA, Xu B, Zhou L, Hu XX, Chen W, Chang FJ, Ci HB, Yao JP, Xu YQ, Yao FJ, Liu DH, Zhang WB, Tang BY, Wang ZP, Ou JS. Simvastatin reduces myocardial injury undergoing noncoronary artery cardiac surgery: a randomized controlled trial. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2304-13. doi: 10.1161/ATVBAHA.112.252098. Epub 2012 Jul 12.
PubMed 22796581
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01178710
- Acronym / sponsor ID
- statinstudy1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Aug 2010 (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.
It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.
Detailed description
Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery.
Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Simvastatin |
| untreated | No intervention | –control |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- cyanotic congenital heart disease
- noncyanotic congenital heart disease with pulmonary hypertension
- Heart valve disease,
- other heart and great artery diseases need heart or great artery surgery
Key exclusion criteria (5 listed)
- Coronary artery disease
- under 10-year-old.
- noncyanotic congenital heart disease without pulmonary hypertension
- poor liver function such AST elevated,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: simcor20 mg per day, start at 5 days before surgery and continue for one year. For some congenital heart diseases which other drugs such as digoxin, antistone, furosemide were prescribed less than half year, simvastatin will be prescribed less than half year. | Drug | treatment |
Primary outcome
plasma troponin T level
Time frame: within the first 7 days after surgery
The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.
1 secondary outcome
the index of B ultrasound on heart
Time frame: one year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Results publication: PubMed 11723015White CW, Gobel FL, Campeau L, Knatterud GL, Forman SA, Forrester JS, Geller NL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Rosenberg Y, Terrin ML; Post Coronary Artery Bypass Graft Trial Investigators. Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001 Nov 27;104(22):2660-5. doi: 10.1161/hc4701.099730.
- Results publication: PubMed 16061117Ali IS, Buth KJ. Preoperative statin use and outcomes following cardiac surgery. Int J Cardiol. 2005 Aug 3;103(1):12-8. doi: 10.1016/j.ijcard.2004.06.006. Epub 2004 Nov 6.
- Results publication: PubMed 16844920Greer JJ, Kakkar AK, Elrod JW, Watson LJ, Jones SP, Lefer DJ. Low-dose simvastatin improves survival and ventricular function via eNOS in congestive heart failure. Am J Physiol Heart Circ Physiol. 2006 Dec;291(6):H2743-51. doi: 10.1152/ajpheart.00347.2006. Epub 2006 Jul 14.
- Derived from this study: PubMed 22796581Almansob MA, Xu B, Zhou L, Hu XX, Chen W, Chang FJ, Ci HB, Yao JP, Xu YQ, Yao FJ, Liu DH, Zhang WB, Tang BY, Wang ZP, Ou JS. Simvastatin reduces myocardial injury undergoing noncoronary artery cardiac surgery: a randomized controlled trial. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2304-13. doi: 10.1161/ATVBAHA.112.252098. Epub 2012 Jul 12.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
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 Rheumatic Heart Disease and Congenital Heart 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jul 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma troponin T level (time frame: within the first 7 days after surgery). 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 NCT01178710, which also lists 4 linked publications.
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 26 Jul 2012.