Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
- Conditions
- Myocardial Dysfunction
- Interventions
- Drug: Placebo oral tabletDrug: Bioarginine
- Registration Number
- NCT04626375
- Lead Sponsor
- Federico II University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Low values of mechanical-energy efficiency
- Sinus rhytm
- Atrial fibrillation
- Taking Beta blockers
- Pregnancy
- Cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo oral tablet Placebo (2 vials per os without active substance every 12 hours) Bioarginine Bioarginine Bioarginine (2 vials per os of 1.66 g every 12 hours)
- Primary Outcome Measures
Name Time Method Change in Myocardial Energetic Efficiency 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
Change in global longitudinal strain 4 week Global longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)
- Secondary Outcome Measures
Name Time Method Variation of circulating non-coding RNA 4 week Variation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients
Trial Locations
- Locations (1)
Ambulatorio Ipertensione e Unità Coronarica Federico II University
🇮🇹Napoli, Italy
Ambulatorio Ipertensione e Unità Coronarica Federico II University🇮🇹Napoli, Italy