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Completed

NCT Number: NCT04740840

Anti Inflammatory Treatment of Hypertension

To investigate the anti-inflammatory effect of amlodipine and levamlodipine in the treatment of hypertension

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

A total of 200 inpatients or outpatients in the Department of cardiovascular medicine of the third people's Hospital of Mianyang City from April 2021 to October 2021, who met the diagnostic criteria of ish2020 international hypertension practice guidelines, were selected and randomly divided into control group and experimental group, with 100 cases in each group. The control group was treated with amlodipine and the experimental group was treated with levoamlodipine. The changes of blood pressure and serum inflammatory factors were observed before and after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ① In line with the diagnostic criteria of ISH2020 International Guidelines for Practice of Hypertension ② Age >18 years old, gender is not limited, during the treatment did not take other drugs that will affect blood pressure: such as antidepressants, oral contraceptives, Chinese herbal medicine, etc.; Voluntary participation and signing of informed consent, and can complete all the visit plan.

Exclusion criteria

  • (1) Those who do not want to take blood tests; (2) Left ventricular ejection fraction < 50%, heart rate <50 beats/min; ③ Acute coronary syndrome (unstable angina pectoris and myocardial infarction); ④ valvular heart disease, congenital heart disease, etc.; Other infectious diseases and malignant tumors; ⑥ Bronchial asthma; ⑦ Abnormal liver function and renal dysfunction (ALT BBB 0 80U/L, CR BBB 1 442mmol/L); Autoimmune diseases or any serious and fatal diseases; ⑨ Receiving lipid-lowering therapy and oral vitamins or antioxidants; They are mentally ill, have no self-awareness, and are unable to express themselves or cooperate with others.

Treatment and study plan

Levamlodipine

Drug

According to the inclusion criteria of the trial, those who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was treated with 2.5mg levamlodipine to lower blood pressure. Abdominal blood was emptying before the start of the trial and at the first and third month of medication.Data on CRP, TNF-α, IL-6, Lp-PLA2 and ATP were collected.

Amlodipine

Drug

According to the inclusion criteria, patients who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was given 5mg amlodipine to lower blood pressure. Fasting blood was collected before the trial and during the first and third months of treatment. CRP, TNF-α, IL-6, Lp-PLA2 and ATP data were collected.

Primary outcomes

  1. After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group

    Time frame: One month after treatment

  2. the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group

    Time frame: One month after treatment

  3. Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs

    Time frame: One month after treatment

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of North Sichuan Medical College

Other

Collaborators

  • First Hospitals affiliated to the China PLA General Hospital

Registry information

Official study title

Comparison of Anti-inflammatory Effects of Amlodipine and Levamlodipine in Patients With Hypertension

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Feb 5, 2021
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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