Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
Condition: Myocardial Dysfunction
MeSH terms: Sprains and Strains
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bioarginine; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week; In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hypertension; Echocardiography; Global Longitudinal Strain