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

July 26, 2022 updated by: Bruno Trimarco, Federico II University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Ambulatorio Ipertensione e Unità Coronarica Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low values of mechanical-energy efficiency
  • Sinus rhytm

Exclusion Criteria:

  • Atrial fibrillation
  • Taking Beta blockers
  • Pregnancy
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo (2 vials per os without active substance every 12 hours)
Drug: Placebo oral tablet
In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Active Comparator: Bioarginine
Bioarginine (2 vials per os of 1.66 g every 12 hours)
Drug: Bioarginine
In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 week
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) (%)
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

Prof. Raffaele Izzo
Prof. Costantino Mancusi

Investigators

  • Study Director: Bruno Trimarco, MF, Federico II University, DPT of Advanced Biomedical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

February 16, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOARGININA

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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