NCT06044194

Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Pilot study to assess the effect of L-Arg and Vit C liposomal supplementation on mitochondrial function in patients with heart failure, through analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC).

Detailed description

Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial. The primary objective of this study is to assess the effect of liposomal L-Arg and Vit C supplementation on mitochondrial function in patients with heart failure, by analysis of the viability of mitochondria isolated from peripheral blood of mononucleate cells (PBMC). Mitochondrial respiratory function of PBMC (in extensive lymphocytes and monocytes) is readily available. These cells are involved in many inflammatory diseases, including those driven by episodes of ischemia-reperfusion, which play a key role in cardiovascular alterations. In particular, the recruitment of T cells and myocardial infiltration are well described during ischemic and non-sischemic heart failure, so the mitochondrial function of PBMC could play a significant role in this immune disorderrelated during heart failure.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	L-arginine and liposomal vitamin C	Once the diagnosis of heart failure is established, patients will be randomized into a double-blind treatment to receive with a 1:1 ratio an oral supplement of 1.66 g L-arginine and 500 mg of liposomal vitamin C once a day (Bioarginine. C , Pharmaceutical Damor) for 3 months (treatment group) or an oral supplement of Placebo once a day for 3 months (control group)

Timeline

• Start date: 2023-03-21
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2023-09-21
• Last updated: 2024-04-22

Locations

1 site across 1 country: Italy