Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
NCT ID: NCT06044194
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
56 participants
INTERVENTIONAL
2023-03-21
2024-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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)
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)
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)
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of heart failure with preserved EF 45%.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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DAMOR Farmaceutici S.p.a.
UNKNOWN
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Stefano Carugo
Director of the Department of Cardio-Thoracic-Vascular Diseases
Locations
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Countries
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Facility Contacts
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Other Identifiers
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3189
Identifier Type: -
Identifier Source: org_study_id
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