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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05772754

Collaborator

(none)

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Genetic: study of molecular and protein pathways	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Partecipants with heart failure and pulmonary hypertensionPartecipants with heart failure and pulmonary hypertension

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Dec 18, 2020

Actual Primary Completion Date :

Jul 20, 2021

Anticipated Study Completion Date :

Dec 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Chronic heart failure partecipants Patients in the Department of Cardiovascular Sciences with signs and symptoms of chronic heart failure, elevated natriuretic peptide levels, left atrial dilatation and/or left ventricular hypertrophy, ejection fraction greater than 50% on echocardiographic evaluation HFpEF	Genetic: study of molecular and protein pathways 42 ml peripheral venous blood sample. Other Names: Analysis of protein profile Genomics analysis
Other: Chronic hert faiure and ejection fraction less than 40% at echocardiographic evaluation Patients admitted to the Department of Cardiovascular Sciences with signs and symptoms of chronic heart failure*, ejection fraction less than 40% at echocardiographic evaluation HFrEF	Genetic: study of molecular and protein pathways 42 ml peripheral venous blood sample. Other Names: Analysis of protein profile Genomics analysis
Other: Partecipants with pulmonary hypertension Patients admitted with advanced HFpEF with development of pulmonary hypertension PH-HFpEF	Genetic: study of molecular and protein pathways 42 ml peripheral venous blood sample. Other Names: Analysis of protein profile Genomics analysis
Other: Partecipants with advanced HFrEF Patients admitted with advanced HFrEF with development of pulmonary hypertension PH-HFrEF	Genetic: study of molecular and protein pathways 42 ml peripheral venous blood sample. Other Names: Analysis of protein profile Genomics analysis
Other: Control Group 12 Controls (CTRL), recruited in the outpatient setting among subjects with cardiovascular disease, in the absence of heart failure	Genetic: study of molecular and protein pathways 42 ml peripheral venous blood sample. Other Names: Analysis of protein profile Genomics analysis

Outcome Measures

Primary Outcome Measures

The first aim of the study is to identify the protein expression to cardiac remodelling [8 months]
Description of protein expression specific to cardiac remodelling underlying chronic heart failure with preserved ejection fraction, in relation to different patient comorbidities, so the primary objective will be to investigate the protein pathways at T0.

Secondary Outcome Measures

Identify interaction variations between protein pathways [6 months]
Identify the interaction networks between proteins using the protein set enrichment study. Using this software, identify the interaction circuits between the most highly expressed proteins, typical of each condition and shared between two clinical categories. This is important to identify the the change in the protein pathway with respect to baseline.
Analyze gene expression in patients with cronic heart failure [6 months]
Identify the most highly expressed genes in the different clinical conditions under investigation.