Effect of Add-on L-Arginine Therapy on Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-Arginine Powder, Placebo.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Add-on L-Arginine Therapy on Clinical Outcome of Heart Failure Patients: A Randomized- Controlled Trial
Overview
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
- Drug L-Arginine Powder
L-arginine 3 gm sachets are used twice daily - Drug Placebo
2 sachets of placebo are administered per day
Primary outcome measures
- Change of Global longitudinal strain value (GLS) of HF patients from the baseline [Time frame: 6 weeks]
Secondary outcome measures (8)
- Change of heart failure symptoms as determined by NYHA classification from baseline [Time frame: 6 weeks]
- Change of the functional abilities (ECG) of the patients as determined by the exercise test from baseline [Time frame: 6 weeks]
- Changes in biomarkers of heart failure as determined by the difference in NT-proBNP levels from baseline [Time frame: 6 weeks]
- Change in quality of life between 2 groups as determined by Minnesota Living with Heart Failure questionnaire [Time frame: 6 weeks]
- Safety profile of the L-Arginine as determined by the change in the mean arterial pressure (MAP) between the 2 groups [Time frame: 6 weeks]
- Change in biomarkers of endothelial dysfunction as determined by the difference in levels of endothelin-1 [Time frame: 6 weeks]
- Change in biomarkers of endothelial dysfunction as determined by the difference in levels of Asymmetric dimethylarginine (ADMA) [Time frame: 6 weeks]
- Safety profile of the L-Arginine as determined by the change in the heart rate (HR) between the 2 groups [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT07394270 · CPH-2025-07-MHS