Anti Inflammatory Treatment of Hypertension

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Levamlodipine; Drug: Amlodipine

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of North Sichuan Medical College
• Collaborators: First Hospitals affiliated to the China PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): April 2, 2012
• Study Completion (Actual): May 2, 2015

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Amlodipine; Levamlodipine; Serum inflammatory factors; Anti inflammatory treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: AHNorthSichuanMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No