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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myocardial Dysfunction

Intervention / Treatment
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* Drug: Bioarginine
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low values of mechanical-energy efficiency Sinus rhytm Exclusion Criteria: Atrial fibrillation Taking Beta blockers Pregnancy Cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Myocardial Energetic Efficiency | 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 | 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 | Variation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Echocardiography, Global Longitudinal Strain