Anti Inflammatory Treatment of Hypertension

NCT04740840 | Completed Phase 2

• 1 other identifier: AHNorthSichuanMC
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Keywords

Levamlodipine; Amlodipine; Serum inflammatory factors; Anti inflammatory treatment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Levamlodipine group

EXPERIMENTAL

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

Drug: Levamlodipine

Amlodipine group

SHAM COMPARATOR

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

Drug: Amlodipine

Interventions

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.

Levamlodipine group

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.

Amlodipine group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hypertension

Interventions

levamlodipine; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 5, 2021
• Study Start: May 1, 2010
• Primary Completion: April 2, 2012
• Study Completion: May 2, 2015
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share