Myocardial DysfunctionPhase 4BIOCARDIONCT04626375
Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
A Phase 4 study testing Bioarginine in people with Myocardial Dysfunction, run by Federico II University at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Dysfunction
- What is being tested?
- Bioarginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2020to 30 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low values of mechanical-energy efficiency
- Sinus rhytm
Who cannot join
- Atrial fibrillation
- Taking Beta blockers
- Pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ambulatorio Ipertensione e Unità Coronarica Federico II University
Naples, 80131
About this study
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.
Read the 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.
- Conditions
- Myocardial Dysfunction
- Being tested
- Bioarginine, Placebo oral tablet
- Keywords
- Hypertension, Echocardiography, Global Longitudinal Strain
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioarginineDrug
In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week
Placebo oral tabletDrug
In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (2 vials per os without active substance every 12 hours) Receives: Drug: Placebo oral tablet |
| Bioarginine | Active comparator | Bioarginine (2 vials per os of 1.66 g every 12 hours) Receives: Drug: Bioarginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 week
Change in global longitudinal strain
Global longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)
Measured: 4 week
Secondary outcomes (1)
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
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start14 Sep 2020
- Primary completion1 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myocardial DysfunctionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Raffaele Izzo, Prof. Costantino Mancusi
- Responsible party
- Principal investigator, Bruno Trimarco, Federico II University
- Investigators
- Bruno Trimarco, MF, Study director, Federico II University, DPT of Advanced Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626375
- Sponsor's protocol ID
- BIOARGININA
- Acronym
- BIOCARDIO
- Status last verified
- Jul 2022
- First submitted
- 16 Feb 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22249531Karlsen 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.
PubMed 31477137Tschope 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.
PubMed 31489515Bianco 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.
PubMed 31202770Nahum 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.
PubMed 20233858Kalam 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.
PubMed 24860005
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-arginine on Myocardial Energetic Efficiency and Global Longitudinal Strain
- ClinicalTrials.gov ID
- NCT04626375
- Acronym / sponsor ID
- BIOCARDIO / BIOARGININA
- Conditions
- Myocardial Dysfunction
- Keywords
- Hypertension, Echocardiography, Global Longitudinal Strain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Prof. Raffaele Izzo, Prof. Costantino Mancusi
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo (2 vials per os without active substance every 12 hours) |
| Bioarginine | Active comparator | Drug: BioarginineBioarginine (2 vials per os of 1.66 g every 12 hours) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low values of mechanical-energy efficiency
- Sinus rhytm
Key exclusion criteria (4 listed)
- Atrial fibrillation
- Taking Beta blockers
- Pregnancy
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioarginineIn the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week | Drug | Bioarginine |
| Placebo oral tabletIn the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week | Drug | Placebo |
Primary outcome
Change in Myocardial Energetic Efficiency
Time frame: 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
Time frame: 4 week
Global longitudinal strain represent the longitudinal shortening as a percentage (change in length as a proportion to baseline length) (%)
1 secondary outcome
Variation of circulating non-coding RNA
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Results publication: PubMed 22249531Shah 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.
- Results publication: PubMed 31477137Karlsen 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 publication: PubMed 31489515Tschope 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 publication: PubMed 31202770Bianco 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 publication: PubMed 20233858Nahum 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 publication: PubMed 24860005Kalam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Trimarco, MF study director
Federico II University, DPT of Advanced Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioarginine in people with Myocardial Dysfunction, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myocardial Energetic Efficiency (time frame: 4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626375, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.