Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain (BIOCARDIO)
Primary Purpose
Myocardial Dysfunction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bioarginine
Placebo oral tablet
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Dysfunction focused on measuring Hypertension, Echocardiography, Global Longitudinal Strain
Eligibility Criteria
Inclusion Criteria:
- Low values of mechanical-energy efficiency
- Sinus rhytm
Exclusion Criteria:
- Atrial fibrillation
- Taking Beta blockers
- Pregnancy
- Cancer
Sites / Locations
- Ambulatorio Ipertensione e Unità Coronarica Federico II University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Bioarginine
Arm Description
Placebo (2 vials per os without active substance every 12 hours)
Bioarginine (2 vials per os of 1.66 g every 12 hours)
Outcomes
Primary Outcome Measures
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
Change in global longitudinal strain
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
Variation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients
Full Information
NCT ID
NCT04626375
First Posted
February 16, 2020
Last Updated
July 26, 2022
Sponsor
Federico II University
Collaborators
Prof. Raffaele Izzo, Prof. Costantino Mancusi
1. Study Identification
Unique Protocol Identification Number
NCT04626375
Brief Title
Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
Acronym
BIOCARDIO
Official Title
Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
Collaborators
Prof. Raffaele Izzo, Prof. Costantino Mancusi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Dysfunction
Keywords
Hypertension, Echocardiography, Global Longitudinal Strain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 vials per os without active substance every 12 hours)
Arm Title
Bioarginine
Arm Type
Active Comparator
Arm Description
Bioarginine (2 vials per os of 1.66 g every 12 hours)
Intervention Type
Drug
Intervention Name(s)
Bioarginine
Intervention Description
In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Primary Outcome Measure Information:
Title
Change in Myocardial Energetic Efficiency
Description
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
Time Frame
4 week
Title
Change in global longitudinal strain
Description
Global longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Variation of circulating non-coding RNA
Description
Variation of circulating non-coding RNA is evaluated by blood samples of venous blood and expressed as fold change to placebo patients
Time Frame
4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Low values of mechanical-energy efficiency
Sinus rhytm
Exclusion Criteria:
Atrial fibrillation
Taking Beta blockers
Pregnancy
Cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Trimarco, MF
Organizational Affiliation
Federico II University, DPT of Advanced Biomedical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ambulatorio Ipertensione e Unità Coronarica Federico II University
City
Napoli
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22249531
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. No abstract available. Erratum In: Circulation. 2013 Mar 5;127(9):e479.
Results Reference
result
PubMed Identifier
31477137
Citation
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.
Results Reference
result
PubMed Identifier
31489515
Citation
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.
Results Reference
result
PubMed Identifier
31202770
Citation
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.
Results Reference
result
PubMed Identifier
20233858
Citation
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.
Results Reference
result
PubMed Identifier
24860005
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 23.
Results Reference
result
Learn more about this trial
Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
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