Coronary Artery DiseaseNCT05562687
Association Between Some Polymorphisms in Apelin/ Apelin Receptor Genes and Coronary Artery Disease in Syrian Patients
An observational study of Coronary Artery Disease and Hypertension, run by Damascus University at 1 site in Syria.
Trial summary
The apelin-APJ signaling pathway has emerged as an important novel mediator of cardiovascular control and blood pressure homeostasis. Genetic variation in apelin and its receptors likely contributes to essential hypertension, in addition to a range of traditional risk factors. Read more about this study
- Who is it for?
- Ages 30 to 78 years
- Conditions the study is for
- Coronary Artery Disease, Hypertension
- How many people
- 223 participants
- Where
- 1 siteSyria
- Study dates
- 15 Dec 2019to 18 Aug 2022
- Phase
- Observational
- 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 30 to 78 years
- All sexes
- Adult, Older adult
Study population: * Control group: subjects who do not have any heart disease, hypertension, or other chronic \&inflammatory diseases, and their coronary arteries are normal. * CAD group with essential hypertension: subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have high blood pressure * CAD group without essential hypertension: subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have normal blood pressure * Hypertension group without CAD: the subjects were characterized by the normal coronary artery and high blood pressure.
Who may be able to join
- Control group: the subjects were characterized by no history of angina and other heart disease or hypertension, and do not have other chronic or inflammatory diseases.
- They represent a normal resting ECG and normal exercise ECG stress testing. And the angiography showed the absence of any stenosis of the coronary arteries.
- They were matched with CAD patients according to age, gender and ethnicity.
- CAD group with essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and high blood pressure (the average of three blood pressure readings was at least 140 mmHg systolic or 90 mmHg diastolic).
- CAD group without essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and normal blood pressure.
- Hypertension group without CAD: the subjects were characterized by the normal coronary artery and high blood pressure. And they were characterized by no history of angina and other heart disease or hypertension, and do not have other chronic or inflammatory diseases.
Who cannot join
- Individuals with valvular heart disease, cardiomyopathy, chronic kidney disease, diabetes, and inflammatory disease were excluded
Trial locations and contacts
1 site in 1 country.
Syria1 site
Damascus University- Faculty of Pharmacy- Research and Graduate Studies Laboratory
Damascus, 011
About this study
Official title: Investigation of Association Between Single Nucleotide Polymorphisms in Genes of the Apelin/ APJ System (-1860T>C & G212A) and CAD Risk and Hypertension in Syrian Patients
The apelin-APJ signaling pathway has emerged as an important novel mediator of cardiovascular control and blood pressure homeostasis. Genetic variation in apelin and its receptors likely contributes to essential hypertension, in addition to a range of traditional risk factors. Thus, a study will be conducted on Syrian patients with hypertension and coronary artery disease to investigate some of the single polymorphisms in the apelin gene and its receptor that may be responsible for the development of these diseases, and to link the levels of this peptide and its receptor in the blood with these polymorphisms and the percentage of these diseases (as shown by many Modern Global Reference Studies).
Read the detailed description
Blood levels of apelin and its receptor will be determined in patients and controls, and correlated with hypertension and coronary artery disease. And the allelic and genotypic frequencies of the G212A single polymorphism nucleotide of the apelin receptor gene and the -1860T>C single polymorphism nucleotide of the apelin gene in the study groups. And evaluation the functional role of A allele in hypertension. As well as investigating the association between: the genotypes of the apelin gene and the levels of apelin in the plasma, the genotypes of the apelin receptor gene and the levels of APJ in the plasma in the study groups. And link the polymorphism of the apelin gene with the polymorphism of the apelin receptor gene. And to determine the correlation between the presence of the studied SNPs and some traditional risk factors for coronary artery disease, which are age, hypertension, the onset age of hypertension, smoking, BMI, cholesterol and triglyceride levels in the blood, and family history of CAD.
- Conditions
- Coronary Artery Disease, Hypertension
- Keywords
- Apelin, Apelin receptor (APJ), Coronary Artery Disease (CAD), Hypertension, apelin -1860T>C polymorphism, APJ G212A polymorphism
- Medical subject headings
- Coronary Artery Disease, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | subjects who do not have any heart disease, hypertension, or other chronic \&inflammatory diseases, and their coronary arteries are normal | |
| CAD group with essential hypertension | subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have high blood pressure | |
| CAD group without essential hypertension | subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have normal blood pressure | |
| Hypertension group without CAD | the subjects were characterized by the normal coronary artery and high blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood apelin concentrations
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis.
Measured: Collecting blood samples before angiography
Blood apelin receptor (APJ) concentrations
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Measured: Collecting blood samples before angiography
The allelic and genotypic frequencies of the -1860T>C single polymorphism nucleotides of the apelin genes
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis
Measured: Collecting blood samples before angiography
The allelic and genotypic frequencies of the G212A single polymorphism nucleotides of the apelin receptor genes
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis.
Measured: Collecting blood samples before angiography
Secondary outcomes (6)
BMI
measurement of body weight and height will be recorded to calculate the body mass index
Measured: before angiography
Measurement of blood pressure
Hypertension was diagnosed when the average of three blood pressure readings was at least 140 mmHg systolic or 90 mmHg diastolic, or in the event the individuals were taking antihypertensive medication
Measured: before angiography
Plasma levels of triglycerides (TG)
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Measured: Collecting blood samples before angiography
total cholesterol (TC) levels in plasma
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Measured: Collecting blood samples before angiography
high-density lipoprotein cholesterol (HDL-C) levels in plasma
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Measured: Collecting blood samples before angiography
low-density lipoprotein cholesterol (LDL-C)
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 3000 g for 10 min, then plasma specimens were stored at -80°C until analysis
Measured: Collecting blood samples before angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start15 Dec 2019
- Primary completion5 Jan 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hussam Eddin Mohammed Shibli, PhD, Study director, Damascus university, ASPU Al-Sham Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562687
- Sponsor's protocol ID
- UDFP-Chemical-02-2022
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang T, Liu C, Jia L, Ding J. The association between apelin polymorphisms and hypertension in China: A meta-analysis. J Renin Angiotensin Aldosterone Syst. 2019 Jan-Mar;20(1):1470320319827204. doi: 10.1177/1470320319827204.
PubMed 30755060Zhong JC, Zhang ZZ, Wang W, McKinnie SMK, Vederas JC, Oudit GY. Targeting the apelin pathway as a novel therapeutic approach for cardiovascular diseases. Biochim Biophys Acta Mol Basis Dis. 2017 Aug;1863(8):1942-1950. doi: 10.1016/j.bbadis.2016.11.007. Epub 2016 Nov 4.
PubMed 27825851Jin W, Su X, Xu M, Liu Y, Shi J, Lu L, Niu W. Interactive association of five candidate polymorphisms in Apelin/APJ pathway with coronary artery disease among Chinese hypertensive patients. PLoS One. 2012;7(12):e51123. doi: 10.1371/journal.pone.0051123. Epub 2012 Dec 3.
PubMed 23226564Falcone C, Bozzini S, Schirinzi S, Buzzi MP, Boiocchi C, Totaro R, Bondesan M, Pelissero G. APJ polymorphisms in coronary artery disease patients with and without hypertension. Mol Med Rep. 2012 Feb;5(2):321-5. doi: 10.3892/mmr.2011.685. Epub 2011 Nov 21.
PubMed 22109355Akcilar R, Yumun G, Bayat Z, Donbaloglu O, Erselcan K, Ece E, Kokdasgil H, Genc O. Characterization of the apelin -1860T>C polymorphism in Turkish coronary artery disease patients and healthy individuals. Int J Physiol Pathophysiol Pharmacol. 2015 Dec 25;7(4):165-71. eCollection 2015.
PubMed 27073592Huang F, Zhu P, Huang Q, Yuan Y, Lin F, Li Q. Associations between gene polymorphisms of the apelin-APJ system and the risk of hypertension. Blood Press. 2016 Aug;25(4):257-62. doi: 10.3109/08037051.2016.1156905. Epub 2016 Jun 24.
PubMed 27338090Nowzari Z, Masoumi M, Nazari-Robati M, Akbari H, Shahrokhi N, Asadikaram G. Association of polymorphisms of leptin, leptin receptor and apelin receptor genes with susceptibility to coronary artery disease and hypertension. Life Sci. 2018 Aug 15;207:166-171. doi: 10.1016/j.lfs.2018.06.007. Epub 2018 Jun 6.
PubMed 29883719Castan-Laurell I, Dray C, Valet P. The therapeutic potentials of apelin in obesity-associated diseases. Mol Cell Endocrinol. 2021 Jun 1;529:111278. doi: 10.1016/j.mce.2021.111278. Epub 2021 Apr 7.
PubMed 33838166Abd-Alkareem MH, Mohammed Shibli HE, Alquobaili FA. Reduced plasma APJ levels and APLNR G212A polymorphism in Syrian patients with coronary artery disease. Curr Med Res Opin. 2026 Mar;42(3):439-449. doi: 10.1080/03007995.2026.2668774. Epub 2026 May 28.
PubMed 42207182
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Association Between Single Nucleotide Polymorphisms in Genes of the Apelin/ APJ System (-1860T>C & G212A) and CAD Risk and Hypertension in Syrian Patients
- ClinicalTrials.gov ID
- NCT05562687
- Acronym / sponsor ID
- UDFP-Chemical-02-2022
- Conditions
- Coronary Artery Disease, Hypertension
- Keywords
- Apelin, Apelin receptor (APJ), Coronary Artery Disease (CAD), Hypertension, apelin -1860T>C polymorphism, APJ G212A polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 3 Oct 2022 (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.
The apelin-APJ signaling pathway has emerged as an important novel mediator of cardiovascular control and blood pressure homeostasis. Genetic variation in apelin and its receptors likely contributes to essential hypertension, in addition to a range of traditional risk factors. Thus, a study will be conducted on Syrian patients with hypertension and coronary artery disease to investigate some of the single polymorphisms in the apelin gene and its receptor that may be responsible for the development of these diseases, and to link the levels of this peptide and its receptor in the blood with these polymorphisms and the percentage of these diseases (as shown by many Modern Global Reference Studies).
Detailed description
Blood levels of apelin and its receptor will be determined in patients and controls, and correlated with hypertension and coronary artery disease. And the allelic and genotypic frequencies of the G212A single polymorphism nucleotide of the apelin receptor gene and the -1860T>C single polymorphism nucleotide of the apelin gene in the study groups. And evaluation the functional role of A allele in hypertension. As well as investigating the association between: the genotypes of the apelin gene and the levels of apelin in the plasma, the genotypes of the apelin receptor gene and the levels of APJ in the plasma in the study groups. And link the polymorphism of the apelin gene with the polymorphism of the apelin receptor gene. And to determine the correlation between the presence of the studied SNPs and some traditional risk factors for coronary artery disease, which are age, hypertension, the onset age of hypertension, smoking, BMI, cholesterol and triglyceride levels in the blood, and family history of CAD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –subjects who do not have any heart disease, hypertension, or other chronic \&inflammatory diseases, and their coronary arteries are normal |
| CAD group with essential hypertension | – | –subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have high blood pressure |
| CAD group without essential hypertension | – | –subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have normal blood pressure |
| Hypertension group without CAD | – | –the subjects were characterized by the normal coronary artery and high blood pressure |
Who may qualify
- Ages
- 30 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Control group: subjects who do not have any heart disease, hypertension, or other chronic \&inflammatory diseases, and their coronary arteries are normal. * CAD group with essential hypertension: subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have high blood pressure * CAD group without essential hypertension: subjects who have stenosis (at least 70%) of one of the main coronary arteries or its branches and have normal blood pressure * Hypertension group without CAD: the subjects were characterized by the normal coronary artery and high blood pressure.
Key inclusion criteria (6 listed)
- Control group: the subjects were characterized by no history of angina and other heart disease or hypertension, and do not have other chronic or inflammatory diseases.
- They represent a normal resting ECG and normal exercise ECG stress testing. And the angiography showed the absence of any stenosis of the coronary arteries.
- They were matched with CAD patients according to age, gender and ethnicity.
- CAD group with essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and high blood pressure (the average of three blood pressure readings was at least 140 mmHg systolic or 90 mmHg diastolic).
- CAD group without essential hypertension: the subjects were characterized by at least 70% stenosis in any coronary artery and normal blood pressure.
Key exclusion criteria (1 listed)
- Individuals with valvular heart disease, cardiomyopathy, chronic kidney disease, diabetes, and inflammatory disease were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood apelin concentrations
Time frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis.
Blood apelin receptor (APJ) concentrations
Time frame: Collecting blood samples before angiography
Blood samples will be obtained after a 10-h overnight fast before angiography and centrifuged at 1000 g for 10 min, then plasma specimens were stored at -80°C until analysis
The allelic and genotypic frequencies of the -1860T>C single polymorphism nucleotides of the apelin genes
Time frame: Collecting blood samples before angiography
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis
The allelic and genotypic frequencies of the G212A single polymorphism nucleotides of the apelin receptor genes
Time frame: Collecting blood samples before angiography
Genomic DNA will be extracted from peripheral blood sample, after that DNA will be stored in a deep freezer (-80°C) until the genetic analysis.
6 secondary outcomes
BMI
Time frame: before angiography
Measurement of blood pressure
Time frame: before angiography
Plasma levels of triglycerides (TG)
Time frame: Collecting blood samples before angiography
total cholesterol (TC) levels in plasma
Time frame: Collecting blood samples before angiography
high-density lipoprotein cholesterol (HDL-C) levels in plasma
Time frame: Collecting blood samples before angiography
low-density lipoprotein cholesterol (LDL-C)
Time frame: Collecting blood samples before angiography
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 1 Apr 2026.
- Background: PubMed 30755060Wang T, Liu C, Jia L, Ding J. The association between apelin polymorphisms and hypertension in China: A meta-analysis. J Renin Angiotensin Aldosterone Syst. 2019 Jan-Mar;20(1):1470320319827204. doi: 10.1177/1470320319827204.
- Background: PubMed 27825851Zhong JC, Zhang ZZ, Wang W, McKinnie SMK, Vederas JC, Oudit GY. Targeting the apelin pathway as a novel therapeutic approach for cardiovascular diseases. Biochim Biophys Acta Mol Basis Dis. 2017 Aug;1863(8):1942-1950. doi: 10.1016/j.bbadis.2016.11.007. Epub 2016 Nov 4.
- Background: PubMed 23226564Jin W, Su X, Xu M, Liu Y, Shi J, Lu L, Niu W. Interactive association of five candidate polymorphisms in Apelin/APJ pathway with coronary artery disease among Chinese hypertensive patients. PLoS One. 2012;7(12):e51123. doi: 10.1371/journal.pone.0051123. Epub 2012 Dec 3.
- Background: PubMed 22109355Falcone C, Bozzini S, Schirinzi S, Buzzi MP, Boiocchi C, Totaro R, Bondesan M, Pelissero G. APJ polymorphisms in coronary artery disease patients with and without hypertension. Mol Med Rep. 2012 Feb;5(2):321-5. doi: 10.3892/mmr.2011.685. Epub 2011 Nov 21.
- Background: PubMed 27073592Akcilar R, Yumun G, Bayat Z, Donbaloglu O, Erselcan K, Ece E, Kokdasgil H, Genc O. Characterization of the apelin -1860T>C polymorphism in Turkish coronary artery disease patients and healthy individuals. Int J Physiol Pathophysiol Pharmacol. 2015 Dec 25;7(4):165-71. eCollection 2015.
- Background: PubMed 27338090Huang F, Zhu P, Huang Q, Yuan Y, Lin F, Li Q. Associations between gene polymorphisms of the apelin-APJ system and the risk of hypertension. Blood Press. 2016 Aug;25(4):257-62. doi: 10.3109/08037051.2016.1156905. Epub 2016 Jun 24.
- Background: PubMed 29883719Nowzari Z, Masoumi M, Nazari-Robati M, Akbari H, Shahrokhi N, Asadikaram G. Association of polymorphisms of leptin, leptin receptor and apelin receptor genes with susceptibility to coronary artery disease and hypertension. Life Sci. 2018 Aug 15;207:166-171. doi: 10.1016/j.lfs.2018.06.007. Epub 2018 Jun 6.
- Background: PubMed 33838166Castan-Laurell I, Dray C, Valet P. The therapeutic potentials of apelin in obesity-associated diseases. Mol Cell Endocrinol. 2021 Jun 1;529:111278. doi: 10.1016/j.mce.2021.111278. Epub 2021 Apr 7.
- Derived from this study: PubMed 42207182Abd-Alkareem MH, Mohammed Shibli HE, Alquobaili FA. Reduced plasma APJ levels and APLNR G212A polymorphism in Syrian patients with coronary artery disease. Curr Med Res Opin. 2026 Mar;42(3):439-449. doi: 10.1080/03007995.2026.2668774. Epub 2026 May 28.
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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.
Hussam Eddin Mohammed Shibli, PhD study director
Damascus university, ASPU Al-Sham Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hypertension, run by Damascus University at 1 site in Syria.
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 6 inclusion and 1 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 1 Apr 2026. 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 Syria. 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?
Blood apelin concentrations (time frame: Collecting blood samples before angiography). The study lists 4 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 NCT05562687, which also lists 9 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 1 Apr 2026.