Status:
RECRUITING
Evaluation of the Effect of Liposomal L-Arg and Vit C Integration on Mitochondrial Function in Patients With Heart Failure
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
DAMOR Farmaceutici S.p.a.
Conditions:
Heart Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of heart failure with preserved EF 45%.
Exclusion
- 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.
Key Trial Info
Start Date :
March 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06044194
Start Date
March 21 2023
End Date
October 31 2024
Last Update
April 22 2024
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Lombardy, Italy, 20122