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临床试验/NCT04626375
NCT04626375已完成4 期

Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain

Federico II University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年9月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
Change in Myocardial Energetic Efficiency

研究概览

简要总结

The study is designed to evaluate the effects of L-arginine on myocardial structure and function and circulating microRNAs in patients with arterial hypertension.

The study will analyze the impact of 4 weeks treatment randomized to L-arginine or placebo, on mechanical-energy efficiency (MEE) and longitudinal strain in patients with arterial hypertension. The investigators will also assess whether the changes in MEE and strain induced by L-arginine treatment is associated with changes in circulating micro RNAs.

详细描述

The patients and controls will be recruited at the Hypertension research center of Federico II university hospital.

The overall duration of the study will be 4 weeks for each participant. Blood pressure, heart rate, echocardiogram and blood sample will be collected for each patients at randomization and after 4 weeks of treatment.

Patients or controls will be randomized to receive bioarginine (up to 2 vials per os of 1.66 g every 12 hours) or placebo (up to 2 vials per os without active substance every 12 hours). Before the start of treatment, patients will receive a peripheral venous blood sample (10-12 ml), which will be identified through the use of an alphanumeric code (PRE-XXXYYY). In addition, patients will undergo full echocardiographic examination (the parameters will be reported in a password-protected database, using the same identification codes used for blood sampling). The duration of the treatment will be 4 weeks. At the end of the treatment, the patients will receive a peripheral venous blood sample (10-12 ml) which will be identified through the use of an alphanumeric code (POST-XXXYYY) and full echocardiographic examination.

In some controls, we will run an explorative study to verify the eventual impact of Bioarginine on standardized physical exercise. Healthy controls will undergo a physical exercise according to their preference, at baseline and after 4 weeks of treatment or placebo. Ear lobe blood samples are taken before and after the effort and analyzed for serum lactate content using the reflectance photometric enzymatic reaction method. All L-arginine and placebo, made up of the L-arginine vehicle without the active substance, will be offered free of charge by the Farmaceutici DAMOR company.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low values of mechanical-energy efficiency
  • Sinus rhytm

排除标准

  • Atrial fibrillation
  • Taking Beta blockers
  • Pregnancy

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo (2 vials per os without active substance every 12 hours)

干预措施: Placebo oral tablet (Drug)

Bioarginine

Active Comparator

Bioarginine (2 vials per os of 1.66 g every 12 hours)

干预措施: Bioarginine (Drug)

结局指标

主要结局

Change in Myocardial Energetic Efficiency

时间窗: 4 week

Myocardial Energetic Efficiency is calculated as SV/HR/60/LV mass measuring the amount of blood pumped by left ventricle each second per each gram of left ventricular mass

Change in global longitudinal strain

时间窗: 4 week

Global longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)

次要结局

  • Variation of circulating non-coding RNA(4 week)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Trimarco

Full Professor

Federico II University

研究点 (1)

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