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

NCT ID: NCT05772754

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2024-12-16

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

study of molecular and protein pathways

Intervention Type: GENETIC

42 ml peripheral venous blood sample.

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

Group Type: OTHER

study of molecular and protein pathways

Intervention Type: GENETIC

42 ml peripheral venous blood sample.

Partecipants with pulmonary hypertension

Patients admitted with advanced HFpEF with development of pulmonary hypertension PH-HFpEF

Group Type: OTHER

study of molecular and protein pathways

Intervention Type: GENETIC

42 ml peripheral venous blood sample.

Partecipants with advanced HFrEF

Patients admitted with advanced HFrEF with development of pulmonary hypertension PH-HFrEF

Group Type: OTHER

study of molecular and protein pathways

Intervention Type: GENETIC

42 ml peripheral venous blood sample.

Control Group

12 Controls (CTRL), recruited in the outpatient setting among subjects with cardiovascular disease, in the absence of heart failure

Group Type: OTHER

study of molecular and protein pathways

Intervention Type: GENETIC

42 ml peripheral venous blood sample.

Interventions

study of molecular and protein pathways

42 ml peripheral venous blood sample.

Intervention Type: GENETIC

Other Intervention Names

Analysis of protein profile; Genomics analysis

Eligibility Criteria

Inclusion Criteria

• heart failure patients

Exclusion Criteria

• patients suffering from infectious diseases and serious infectious diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Liuzzo Giovanna

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Gemelli

Roma, , Italy

Countries

Italy

Other Identifiers

3671

Identifier Type: -

Identifier Source: org_study_id