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

February 1, 2026 updated by: Sara Araby, German University in Cairo

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

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%

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L-Arginine Arm
Patients in this arm will be administered 6 gm L-arginine per day
Drug: L-Arginine Powder
L-arginine 3 gm sachets are used twice daily
Placebo Comparator: Placebo Arm
Patients in this arm will take 6 gm placebo per day
Drug: Placebo
2 sachets of placebo are administered per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Global longitudinal strain value (GLS) of HF patients from the baseline
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of heart failure symptoms as determined by NYHA classification from baseline
Time Frame: 6 weeks
6 weeks
Change of the functional abilities (ECG) of the patients as determined by the exercise test from baseline
Time Frame: 6 weeks
6 weeks
Changes in biomarkers of heart failure as determined by the difference in NT-proBNP levels from baseline
Time Frame: 6 weeks
6 weeks
Change in quality of life between 2 groups as determined by Minnesota Living with Heart Failure questionnaire
Time Frame: 6 weeks
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
6 weeks
Change in biomarkers of endothelial dysfunction as determined by the difference in levels of endothelin-1
Time Frame: 6 weeks
6 weeks
Change in biomarkers of endothelial dysfunction as determined by the difference in levels of Asymmetric dimethylarginine (ADMA)
Time Frame: 6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German University in Cairo

Collaborators

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPH-2025-07-MHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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