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

Heart Failure Clinical Trial

— Mito-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044194
• Other study ID #: 3189
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Milan	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	DAMOR Farmaceutici S.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of liposomal L-Arg and Vit C	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).	3 months