NCT05772754

Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction by New Omics Technologies

Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction HFpEF by New Omics Technologies

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Heart failure with preserved ejection fraction nowadays affects about half of all patients with heart failure. In the general population, the prevalence of this subclass of heart failure (HFpEF, ed.) increases as the age of patients increases, especially in those over 65 years of age, and it has a significant gender. The study is to investigate the molecular pathways, predominantly protein patterns, involved in cardiac remodeling peculiar to heart failure with preserved ejection fraction (HFpEF) by comparing them with remodeling pathways and protein pattern alterations in patients with HFrEF. In addition, the study aims to identify molecular alterations that would allow early identification of the development of PH-HFpEF and PH-HFrEF, affecting the female gender more

Detailed description

The study, placing itself within the framework of Translational Research, aims to gain a greater understanding of the different phenotypes of patients with HFpEF, to expand knowledge of the specific immune profile, and to identify new therapeutic targets for a heterogeneous clinical syndrome, to date lacking effective medical therapy. It is also proposed to find potential biomarkers with which to distinguish early between the two subclasses of decompensation and protein alterations related to the possible development of pulmonary hypertension in patients with HFpEF and HFrEF (PH-HFpEF and PH- HFrEF, respectively). Patients who will take part in the study, following enrollment carried out on an inpatient or outpatient basis (being inpatients and control group subjects, respectively), will have follow-up visits at two times (at 1 month and at 6 months), in conjunction with regularly scheduled medical checkups, according to Good Clinical Practice.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
GENETIC	study of molecular and protein pathways	42 ml peripheral venous blood sample.

Timeline

• Start date: 2020-12-18
• Primary completion: 2021-07-20
• Completion: 2024-12-16
• First posted: 2023-03-16
• Last updated: 2023-03-20

Locations

1 site across 1 country: Italy