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NCT Number: NCT07394270

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

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%

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Arginine Powder

Drug

L-arginine 3 gm sachets are used twice daily

Placebo

Drug

2 sachets of placebo are administered per day

Primary outcomes

  1. Change of Global longitudinal strain value (GLS) of HF patients from the baseline

    Time frame: 6 weeks

Secondary outcomes

  1. Change of heart failure symptoms as determined by NYHA classification from baseline

    Time frame: 6 weeks

  2. Change of the functional abilities (ECG) of the patients as determined by the exercise test from baseline

    Time frame: 6 weeks

  3. Changes in biomarkers of heart failure as determined by the difference in NT-proBNP levels from baseline

    Time frame: 6 weeks

  4. Change in quality of life between 2 groups as determined by Minnesota Living with Heart Failure questionnaire

    Time frame: 6 weeks

  5. 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

  6. Change in biomarkers of endothelial dysfunction as determined by the difference in levels of endothelin-1

    Time frame: 6 weeks

  7. Change in biomarkers of endothelial dysfunction as determined by the difference in levels of Asymmetric dimethylarginine (ADMA)

    Time frame: 6 weeks

  8. Safety profile of the L-Arginine as determined by the change in the heart rate (HR) between the 2 groups

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Solayman, PhD

CONTACT

[email protected]

+201005882550

Sara Araby, Msc

CONTACT

[email protected]

+201008662223

Sponsors and collaborators

Lead sponsor

German University in Cairo

Other

Collaborators

  • Ain Shams University

Registry information

Official study title

Effect of Add-on L-Arginine Therapy on Clinical Outcome of Heart Failure Patients: A Randomized- Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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