Heart Failure
Conditions
Keywords
Heart failure, Drug repurposing, L-Arginine, Add-on therapy, HFrEF
Brief summary
Heart failure is considered one of the greatest challenges globally. There are various treatment strategies for heart failure. L-Arginine is an amino acid that was found to have beneficial effect on vasculature. This study aims to study the benefits and side effects of using L-arginine on the patients with ejection fraction \<40%
Interventions
L-arginine 3 gm sachets are used twice daily
DRUGPlacebo
2 sachets of placebo are administered per day
Sponsors
German University in Cairo
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with EF \<40% * eGFR \>30 mL/min/1.73 m2 * Stable patients * Capable and willing to provide written consent
Exclusion criteria
* Patients with implantable cardioverter-defibrillator * Pregnant or lactating fmeales * Patients with a history of sensitivity to L-Arginine or any of the excipients * Acute heart failure patients * Patients use L-arginine supplementation. * Patients with active herpes disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Global longitudinal strain value (GLS) of HF patients from the baseline | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change of heart failure symptoms as determined by NYHA classification from baseline | 6 weeks |
| Change of the functional abilities (ECG) of the patients as determined by the exercise test from baseline | 6 weeks |
| Changes in biomarkers of heart failure as determined by the difference in NT-proBNP levels from baseline | 6 weeks |
| Change in quality of life between 2 groups as determined by Minnesota Living with Heart Failure questionnaire | 6 weeks |
| Safety profile of the L-Arginine as determined by the change in the mean arterial pressure (MAP) between the 2 groups | 6 weeks |
| Change in biomarkers of endothelial dysfunction as determined by the difference in levels of endothelin-1 | 6 weeks |
| Change in biomarkers of endothelial dysfunction as determined by the difference in levels of Asymmetric dimethylarginine (ADMA) | 6 weeks |
| Safety profile of the L-Arginine as determined by the change in the heart rate (HR) between the 2 groups | 6 weeks |
Countries
Egypt
Contacts
CONTACTSara Araby, Msc
CONTACTMohamed Solayman, PhD
Outcome results
None listed