Mito-HF: 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 (Other)

Overall Status

Recruiting

CT.gov ID

NCT06044194

Collaborator

DAMOR Farmaceutici S.p.a. (Other)

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: L-arginine and liposomal vitamin C	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trialPilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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)	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)
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)

Arm

Intervention/Treatment

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)

Drug: L-arginine and liposomal vitamin C

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)

Outcome Measures

Primary Outcome Measures

To assess the effect of liposomal L-Arg and Vit C [3 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Milan	Lombardia	Italy	20122

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefano Carugo, Director of the Department of Cardio-Thoracic-Vascular Diseases, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

ClinicalTrials.gov Identifier:

NCT06044194

Other Study ID Numbers:

3189

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stefano Carugo, Director of the Department of Cardio-Thoracic-Vascular Diseases, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Sep 21, 2023