Investigation of MDR1 Gene Polymorphism and Losartan Plasma Concentration in Patients Undergoing Hypertensive Episodes While Under Losartan Treatment

NCT05349825 | Completed DMC

• 1 other identifier: 4921
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 drugs/foreign 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

Conditions

Hypertension

Keywords

Losartan; MDR1; Genetic polymorphism; EXP3174; Hypertension

Outcome Measures

Primary Outcomes (1)

• MDR1 gene polimorphism does not influence losartan consantration nevertheless changes blood pressure lowering effect of losartan

  50 patients receiving anti-hypertensive treatment with losartan, presenting to the ED with a hypertensive episode and 50 patients whose blood pressure was regulated while receiving losartan treatment and who presented to the ED for reasons other than hypertensive episode. Compare two groups losartan consantration and MDR1 gene polymorphyms

  at least six weeks under losartan treatment

Study Arms (2)

Patients with Hypertensive episode

50 individuals presenting with a hypertensive episode (patients under 60, \>140/90 mmHg, patients over 60, \>150/90 mmHg, according to the JNC8 guidelines) while under losartan treatment

Diagnostic Test: Genetic analysis and Losartan plazma level measurement

Patients with controlled hypertension

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.

Diagnostic Test: Genetic analysis and Losartan plazma level measurement

Interventions

Genetic analysis and Losartan plazma level measurement DIAGNOSTIC_TEST

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 -20°C until the tandem mass spectrometry measurement. The blood samples in EDTA tubes were then transferred for DNA analysis. . To measure plasma losartan concentration, after the frozen plasma samples stored in the eppendorfs were thawed and brought to room temperature, plasma losartan and EXP3174 levels of the patients were calculated using tandem mass spectrometry

Patients with Hypertensive episode; Patients with controlled hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

. The patient group was comprised of 50 individuals presenting with a hypertensive episode (patients under 60, \>140/90 mmHg, patients over 60, \>150/90 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.

You may qualify if:

• gave their informed consent
• received minimum 25 mg losartan daily for at least six weeks

You may not qualify if:

• refusal to participate in the study
• illiteracy
• pregnant or in lactation period
• hemodynamically unstable (mean arterial pressure \<65mmHg)
• kidney transplantation
• liver failure (CHILD PUGH Class C and higher patients) or renal failure (GFR\<60)
• taking anti-hypertensive drugs other than losartan

Sponsors & Collaborators

• Pamukkale University: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

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 -20°C until the tandem mass spectrometry measurement

MeSH Terms

Conditions

Hypertension

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 27, 2022
• Study Start: October 23, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

TU (1)