BIOCARDIO: Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Low values of mechanical-energy efficiency
-
Sinus rhytm
Exclusion Criteria:
-
Atrial fibrillation
-
Taking Beta blockers
-
Pregnancy
-
Cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ambulatorio Ipertensione e Unità Coronarica Federico II University | Napoli | Italy | 80131 |
Sponsors and Collaborators
- Federico II University
- Prof. Raffaele Izzo
- Prof. Costantino Mancusi
Investigators
- Study Director: Bruno Trimarco, MF, Federico II University, DPT of Advanced Biomedical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIOARGININA