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

Myocardial Dysfunction Clinical Trial

— BIOCARDIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626375
• Other study ID #: BIOARGININA
• Status: Completed
• Phase: Phase 4
• Start date: September 14, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: July 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 30, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Low values of mechanical-energy efficiency

• Sinus rhytm

Exclusion Criteria:

• Atrial fibrillation

• Taking Beta blockers

• Pregnancy

• Cancer

Related Conditions & MeSH terms

• Myocardial Dysfunction
• Sprains and Strains

Intervention

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

Locations

Country	Name	City	State
Italy	Ambulatorio Ipertensione e Unità Coronarica Federico II University	Napoli

Sponsors (3)

Lead Sponsor	Collaborator
Federico II University	Prof. Costantino Mancusi, Prof. Raffaele Izzo

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Bianco CM, Farjo PD, Ghaffar YA, Sengupta PP. Myocardial Mechanics in Patients With Normal LVEF and Diastolic Dysfunction. JACC Cardiovasc Imaging. 2020 Jan;13(1 Pt 2):258-271. doi: 10.1016/j.jcmg.2018.12.035. Epub 2019 Jun 12. Review. — View Citation

Kalam K, Otahal P, Marwick TH. Prognostic implications of global LV dysfunction: a systematic review and meta-analysis of global longitudinal strain and ejection fraction. Heart. 2014 Nov;100(21):1673-80. doi: 10.1136/heartjnl-2014-305538. Epub 2014 May 2 — View Citation

Karlsen S, Dahlslett T, Grenne B, Sjøli B, Smiseth O, Edvardsen T, Brunvand H. Global longitudinal strain is a more reproducible measure of left ventricular function than ejection fraction regardless of echocardiographic training. Cardiovasc Ultrasound. 2 — View Citation

Nahum J, Bensaid A, Dussault C, Macron L, Clémence D, Bouhemad B, Monin JL, Rande JL, Gueret P, Lim P. Impact of longitudinal myocardial deformation on the prognosis of chronic heart failure patients. Circ Cardiovasc Imaging. 2010 May;3(3):249-56. doi: 10 — View Citation

Shah AM, Solomon SD. Myocardial deformation imaging: current status and future directions. Circulation. 2012 Jan 17;125(2):e244-8. doi: 10.1161/CIRCULATIONAHA.111.086348. Review. Erratum in: Circulation. 2013 Mar 5;127(9):e479. — View Citation

Tschöpe C, Senni M. Usefulness and clinical relevance of left ventricular global longitudinal systolic strain in patients with heart failure with preserved ejection fraction. Heart Fail Rev. 2020 Jan;25(1):67-73. doi: 10.1007/s10741-019-09853-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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