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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
L-arginine and liposomal vitamin C
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Mitochondrial, PBMC, L-Arg, Vit C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

No Intervention

Arm Label

Treatment group

Control group

Arm 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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
DAMOR Farmaceutici S.p.a.
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1. Study Identification

Unique Protocol Identification Number
NCT06044194
Brief Title
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Acronym
Mito-HF
Official Title
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
DAMOR Farmaceutici S.p.a.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Mitochondrial, PBMC, L-Arg, Vit C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Placebo Comparator
Arm 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)
Arm Title
Control group
Arm Type
No Intervention
Arm 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)
Intervention Type
Drug
Intervention Name(s)
L-arginine and liposomal vitamin C
Intervention 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) or an oral supplement of Placebo once a day for 3 months (control group)
Primary Outcome Measure Information:
Title
To assess the effect of liposomal L-Arg and Vit C
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Carugo, Principal Investigator
Phone
+390255033579
Email
stefano.carugo@policlinico.mi.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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