Anti Inflammatory Treatment of Hypertension

Sponsor

Afﬁliated Hospital of North Sichuan Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT04740840

Collaborator

First Hospitals affiliated to the China PLA General Hospital (Other)

200

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Levamlodipine Drug: Amlodipine	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Apr 2, 2012

Actual Study Completion Date :

May 2, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levamlodipine group Blood pressure lowering therapy with 2.5mg levamlodipine, plus metoprolol succinate	Drug: Levamlodipine 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.
Sham Comparator: Amlodipine group To receive 5mg amlodipine to lower blood pressure, plus metoprolol succinate	Drug: Amlodipine 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.

Arm

Intervention/Treatment

Experimental: Levamlodipine group

Blood pressure lowering therapy with 2.5mg levamlodipine, plus metoprolol succinate

Drug: Levamlodipine

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.

Sham Comparator: Amlodipine group

To receive 5mg amlodipine to lower blood pressure, plus metoprolol succinate

Drug: Amlodipine

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.

Outcome Measures

Primary Outcome Measures

After treatment, the blood pressure control of L-amlodipine group was better than that of amlodipine group [One month after treatment]
the serum inflammatory factor level of L-amlodipine group was lower than that of amlodipine group [One month after treatment]
Serum ATP level can be used to evaluate the anti-inflammatory effect of hypertension drugs [One month after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.