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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04626375
Acronym
BIOCARDIO
Enrollment
54
Registered
2020-11-12
Start date
2020-09-14
Completion date
2021-08-30
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Dysfunction

Keywords

Hypertension, Echocardiography, Global Longitudinal Strain

Brief summary

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.

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.

Interventions

DRUGBioarginine

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

DRUGPlacebo 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

Sponsors

Prof. Raffaele Izzo
CollaboratorUNKNOWN
Prof. Costantino Mancusi
CollaboratorUNKNOWN
Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Low values of mechanical-energy efficiency * Sinus rhytm

Exclusion criteria

* Atrial fibrillation * Taking Beta blockers * Pregnancy * Cancer

Design outcomes

Primary

MeasureTime frameDescription
Change in Myocardial Energetic Efficiency4 weekMyocardial 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 strain4 weekGlobal longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)

Secondary

MeasureTime frameDescription
Variation of circulating non-coding RNA4 weekVariation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026