Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age ≥18 years
• Diagnosis of heart failure with preserved EF 45%.
Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
RECRUITING
Milan
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2024-10-31
Participants
Target number of participants: 56
Treatments
Placebo_comparator: Treatment group
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)
No_intervention: Control group
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 Placebo for 3 months (control group)
Related Therapeutic Areas
Sponsors
Collaborators: DAMOR Farmaceutici S.p.a.
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico