Evaluating the effects of L-Arginine and Vitamin C on heart function
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
This study is testing if taking L-Arginine and Vitamin C can improve heart function by looking at how they affect energy production in patients with heart failure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Lombardia) |
| Trial ID | NCT06044194 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess how liposomal supplementation of L-Arginine and Vitamin C affects mitochondrial function in patients diagnosed with heart failure. It is a monocentric, prospective, double-blind randomized trial that will analyze the viability of mitochondria isolated from peripheral blood mononuclear cells (PBMC). The study focuses on understanding the role of mitochondrial respiratory function in immune disorders related to heart failure, particularly during ischemic and non-ischemic events.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of heart failure and preserved ejection fraction of 45% or higher.
Not a fit: Patients under 18 years old, those with left ventricular ejection fraction below 45%, or those with certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve mitochondrial function in heart failure patients, potentially enhancing their overall heart health.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving mitochondrial function in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis of heart failure with preserved EF 45%. Exclusion Criteria: * Age \<18 years * Left ventricular ejection fraction \<45% * Valvular heart disease * Previous myocardial infarction or coronary heart disease * Hypertension * Diabetes mellitus * Intolerance to L-arginine and liposomal vitamin C * Pregnancy * Lactation.
Where this trial is running
Milan, Lombardia
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Lombardia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.