Coronary Heart Disease
Conditions
Keywords
molecular pathways, cardiac remodeling, coronary insufficiency
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.
Interventions
GENETICstudy of molecular and protein pathways
42 ml peripheral venous blood sample.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Partecipants with heart failure and pulmonary hypertension
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* heart failure patients
Exclusion criteria
* patients suffering from infectious diseases and serious infectious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed