RecruitingPhase 3NCT06044194

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


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

56 participants

Start Date

Mar 21, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Age ≥18 years
  • Diagnosis of heart failure with preserved EF 45%.

Exclusion Criteria9

  • 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.

Interventions

DRUGL-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)


Locations(1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06044194


Related Trials