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Not yet recruiting NCT07394270

Effect of Add-on L-Arginine Therapy on Heart Failure Patients

Phase II Interventional Heart Failure

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗