NCT07394270

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%

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

December 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

December 23, 2025

Last Update Submit

February 1, 2026

Conditions

Heart Failure

Keywords

Heart failureDrug repurposingL-ArginineAdd-on therapyHFrEF

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

L-Arginine Arm

ACTIVE COMPARATOR

Patients in this arm will be administered 6 gm L-arginine per day

Drug: L-Arginine Powder

Placebo Arm

PLACEBO COMPARATOR

Patients in this arm will take 6 gm placebo per day

Drug: Placebo

Interventions

L-Arginine PowderDRUG

L-arginine 3 gm sachets are used twice daily

L-Arginine Arm
PlaceboDRUG

2 sachets of placebo are administered per day

Placebo Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with EF \<40%
  • eGFR \>30 mL/min/1.73 m2
  • Stable patients
  • Capable and willing to provide written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Sara Araby, Msc

CONTACT

+201008662223sara.araby96@gmail.com

Mohamed Solayman, PhD

CONTACT

+201005882550mohamed.solayman@guc.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc.

Study Record Dates

First Submitted

December 23, 2025

First Posted

February 6, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)