Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
NCT ID: NCT04626375
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2020-09-14
2021-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
L-Arginine Metabolism in Essential Hypertension
NCT00137124
L-arginine Treatment in Mild Hypertension
NCT02894723
L-NMMA Dose-response Study in Healthy Subjects
NCT01070940
The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction
NCT03679780
Impact of Citrulline and Arginine Supplementation on the Post-exercise Hypotension (PEH)
NCT03378596
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo (2 vials per os without active substance every 12 hours)
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
Bioarginine
Bioarginine (2 vials per os of 1.66 g every 12 hours)
Bioarginine
In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sinus rhytm
Exclusion Criteria
* Taking Beta blockers
* Pregnancy
* Cancer
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prof. Raffaele Izzo
UNKNOWN
Prof. Costantino Mancusi
UNKNOWN
Federico II University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bruno Trimarco
Full Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno Trimarco, MF
Role: STUDY_DIRECTOR
Federico II University, DPT of Advanced Biomedical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ambulatorio Ipertensione e Unità Coronarica Federico II University
Napoli, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. No abstract available.
Karlsen S, Dahlslett T, Grenne B, Sjoli 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. 2019 Sep 2;17(1):18. doi: 10.1186/s12947-019-0168-9.
Tschope 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.
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.
Nahum J, Bensaid A, Dussault C, Macron L, Clemence 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: 10.1161/CIRCIMAGING.109.910893. Epub 2010 Mar 16.
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 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIOARGININA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.