Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05349825
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2022-04-18
Brief Title:
Investigation of MDR1 Gene Polymorphism and Losartan Plasma Concentration in Patients Undergoing Hypertensive Episodes While Under Losartan Treatment
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Investigation of MDR1 Multi-Drug Resistance Gene Polymorphism and Losartan Plasma Concentration in Patients Undergoing Hypertensive Episodes While Under Losartan Treatment A Prospective Case-Control Study
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Losartan is an antihypertensive drug belonging to the ARB family It is characterized as the substrate of the Multi Drug Resistance-1 MDR1 drug-efflux protein a pump that ensures the removal of drugsforeign substances out of the cell encoded by the ATP Binding Cassette Subfamily B Member 1 ABCB1 gene A recent line of evidence indicates that potential polymorphisms in this gene tend to alter the absorption transport bioavailability of losartan and indirectly its effectiveness in hypertension control As identified by new research the C3435T G2677T and C1236T polymorphic alleles of the MDR1 gene might alter the bioavailability and thus the effectiveness of losartan
Detailed Description:
This trial was conducted in the emergency services of Gazi University and Pamukkale University The patient group was comprised of 50 individuals presenting with a hypertensive episode patients under 60 14090 mmHg patients over 60 15090 mmHg according to the JNC8 guidelines while under losartan treatment The control group by contrast included 50 patients whose blood pressure was regulated while receiving losartan treatment and who were admitted to the ED for reasons other than hypertensive episode The eligible patients matching the inclusion and exclusion criteria were recruited for the study
Within the scope of this research we included hypertension patients over 18 who gave their informed consent for the study and received minimum 25 mg losartan daily for at least six weeks 50 individuals admitted to the ED due to a hypertensive episode while under losartan treatment were assigned to the patient group while 50 patients whose blood pressure was regulated while receiving losartan treatment and who were admitted to the ED for reasons other than hypertensive episode were included in the control group Those who did not give their consent to participate and did not match the inclusion criteria were excluded from the scope of the study Prior to the trial the participants were assessed based on the pre-defined patient selection criteria and the non-eligible ones were excluded from the trial These exclusion criteria can be listed as refusal to participate in the study illiteracy being under 18 being pregnant and in lactation period being hemodynamically unstable mean arterial pressure 65mmHg undergoing kidney transplantation having liver failure CHILD PUGH Class C and higher patients or renal failure GFR60 and taking anti-hypertensive drugs other than losartanFigure 1
Initially 20 ml of blood was collected from the enrolled patients 10 ml of blood was stored in the tubes with ethylene diamine tetraacetic acid EDTA until Deoxyribonucleic acid DNA isolation was performed at -20 degrees and plasma level was identified The remaining 10 ml was centrifuged at 3500 rpm for 10 min and the plasma was separated The resulting plasmas were stored in the eppendorf tubes at -20C until the tandem mass spectrometry measurement
Within the scope of this research we included hypertension patients over 18 who gave their informed consent for the study and received minimum 25 mg losartan daily for at least six weeks 50 individuals admitted to the ED due to a hypertensive episode while under losartan treatment were assigned to the patient group while 50 patients whose blood pressure was regulated while receiving losartan treatment and who were admitted to the ED for reasons other than hypertensive episode were included in the control group Those who did not give their consent to participate and did not match the inclusion criteria were excluded from the scope of the study Prior to the trial the participants were assessed based on the pre-defined patient selection criteria and the non-eligible ones were excluded from the trial These exclusion criteria can be listed as refusal to participate in the study illiteracy being under 18 being pregnant and in lactation period being hemodynamically unstable mean arterial pressure 65mmHg undergoing kidney transplantation having liver failure CHILD PUGH Class C and higher patients or renal failure GFR60 and taking anti-hypertensive drugs other than losartanFigure 1
Initially 20 ml of blood was collected from the enrolled patients 10 ml of blood was stored in the tubes with ethylene diamine tetraacetic acid EDTA until Deoxyribonucleic acid DNA isolation was performed at -20 degrees and plasma level was identified The remaining 10 ml was centrifuged at 3500 rpm for 10 min and the plasma was separated The resulting plasmas were stored in the eppendorf tubes at -20C until the tandem mass spectrometry measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None