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OpenTrials
Completed

NCT Number: NCT04626375

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ambulatorio Ipertensione e Unità Coronarica Federico II University

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Low values of mechanical-energy efficiency
  • Sinus rhytm

Exclusion criteria

  • Atrial fibrillation
  • Taking Beta blockers
  • Pregnancy
  • Cancer

Treatment and study plan

Bioarginine

Drug

In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week

Placebo oral tablet

Drug

In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week

Primary outcomes

  1. Change in Myocardial Energetic Efficiency

    Time frame: 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

  2. Change in global longitudinal strain

    Time frame: 4 week

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

Secondary outcomes

  1. Variation of circulating non-coding RNA

    Time frame: 4 week

    Variation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Prof. Costantino Mancusi
  • Prof. Raffaele Izzo

Registry information

Acronym: BIOCARDIO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Jul 27, 2022

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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