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

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Coronary Heart Disease

Treatments

Genetic: study of molecular and protein pathways

Study type

Interventional

Funder types

Other

Identifiers

NCT05772754

3671

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

heart failure patients

Exclusion criteria

patients suffering from infectious diseases and serious infectious diseases

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 5 patient groups

Chronic heart failure partecipants

Other group

Description:

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

Treatment:

Genetic: study of molecular and protein pathways

Chronic hert faiure and ejection fraction less than 40% at echocardiographic evaluation

Other group

Description:

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

Treatment:

Genetic: study of molecular and protein pathways

Partecipants with pulmonary hypertension

Other group

Description:

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

Treatment:

Genetic: study of molecular and protein pathways

Partecipants with advanced HFrEF

Other group

Description:

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