NCT04626375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

February 16, 2020

Last Update Submit

July 26, 2022

Conditions

Myocardial Dysfunction

Keywords

HypertensionEchocardiographyGlobal Longitudinal Strain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Variation of circulating non-coding RNA

    4 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (2 vials per os without active substance every 12 hours)

Drug: Placebo oral tablet

Bioarginine

ACTIVE COMPARATOR

Bioarginine (2 vials per os of 1.66 g every 12 hours)

Drug: Bioarginine

Interventions

BioarginineDRUG

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

Bioarginine
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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low values of mechanical-energy efficiency
  • Sinus rhytm

You may not qualify if:

  • Atrial fibrillation
  • Taking Beta blockers
  • Pregnancy
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatorio Ipertensione e Unità Coronarica Federico II University

Napoli, 80131, Italy

Location

Related Publications (6)

  • 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.

    PMID: 22249531RESULT

  • 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.

    PMID: 31477137RESULT

  • 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.

    PMID: 31489515RESULT

  • 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.

    PMID: 31202770RESULT

  • 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.

    PMID: 20233858RESULT

  • 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.

    PMID: 24860005RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bruno Trimarco, MF

    Federico II University, DPT of Advanced Biomedical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

February 16, 2020

First Posted

November 12, 2020

Study Start

September 14, 2020

Primary Completion

August 1, 2021

Study Completion

August 30, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)