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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Enrolling; Phase 3

Conditions: Heart Failure

Treatments: Drug: L-arginine and liposomal vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT06044194

3189

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Treatment group

Placebo Comparator group

Description:

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)

Treatment:

Drug: L-arginine and liposomal vitamin C

Control group

No Intervention group

Description:

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)