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

NCT06044194 | Recruiting Phase 3

• 1 other identifier: 3189
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Mitochondrial; PBMC; L-Arg; Vit C

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment group

PLACEBO COMPARATOR

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

Control group

NO INTERVENTION

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)

Interventions

L-arginine and liposomal vitamin C DRUG

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)

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of heart failure with preserved EF 45%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• DAMOR Farmaceutici S.p.a.: collaborator

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Arginine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardio-Thoracic-Vascular Diseases

Model Details: Pilot, monocentric, national, non-pharmacological, prospective, double-blind randomized trial

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: March 21, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)