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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorGerman University in Cairo

About this 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%

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with EF <40%

eGFR >30 mL/min/1.73 m2

Stable patients

Capable and willing to provide written consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-Arginine Powder

    Drug

    L-arginine 3 gm sachets are used twice daily

  • Placebo

    Drug

    2 sachets of placebo are administered per day

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: L-Arginine ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German University in Cairo

Lead sponsor

Ain Shams University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: