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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic heart failure partecipants | Other | 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 |
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| Chronic hert faiure and ejection fraction less than 40% at echocardiographic evaluation | Other | 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 |
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| Partecipants with pulmonary hypertension | Other | Patients admitted with advanced HFpEF with development of pulmonary hypertension PH-HFpEF |
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| Partecipants with advanced HFrEF | Other | Patients admitted with advanced HFrEF with development of pulmonary hypertension PH-HFrEF |
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| Control Group | Other | 12 Controls (CTRL), recruited in the outpatient setting among subjects with cardiovascular disease, in the absence of heart failure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| study of molecular and protein pathways | Genetic | 42 ml peripheral venous blood sample. |
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| Measure | Description | Time Frame |
|---|---|---|
| The first aim of the study is to identify the protein expression to cardiac remodelling | 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. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identify interaction variations between protein pathways | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli | Roma | 00168 | Italy |
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Partecipants with heart failure and pulmonary hypertension
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| 6 months |
| Analyze gene expression in patients with cronic heart failure | Identify the most highly expressed genes in the different clinical conditions under investigation. | 6 months |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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