NCT05562687

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

September 28, 2022

Last Update Submit

March 27, 2026

Conditions

Keywords

ApelinApelin receptor (APJ)Coronary Artery Disease (CAD)Hypertensionapelin -1860T>C polymorphismAPJ G212A polymorphism

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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

    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.

    Collecting blood samples before angiography

Secondary Outcomes (6)

  • BMI

    before angiography

  • Measurement of blood pressure

    before angiography

  • Plasma levels of triglycerides (TG)

    Collecting blood samples before angiography

  • total cholesterol (TC) levels in plasma

    Collecting blood samples before angiography

  • high-density lipoprotein cholesterol (HDL-C) levels in plasma

    Collecting blood samples before angiography

  • +1 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age30 Years - 78 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with valvular heart disease, cardiomyopathy, chronic kidney disease, diabetes, and inflammatory disease were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University- Faculty of Pharmacy- Research and Graduate Studies Laboratory

Damascus, 011, Syria

Location

Related Publications (8)

  • 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.

    PMID: 30755060BACKGROUND
  • Zhong 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.

    PMID: 27825851BACKGROUND
  • Jin 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.

    PMID: 23226564BACKGROUND
  • Falcone 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.

    PMID: 22109355BACKGROUND
  • Akcilar 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.

    PMID: 27073592BACKGROUND
  • Huang 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.

    PMID: 27338090BACKGROUND
  • Nowzari 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.

    PMID: 29883719BACKGROUND
  • Castan-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.

    PMID: 33838166BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseHypertension

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hussam Eddin Mohammed Shibli, PhD

    Damascus university, ASPU Al-Sham Private University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

December 15, 2019

Primary Completion

January 5, 2022

Study Completion

August 18, 2022

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations