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

Primary Purpose

Coronary Heart Disease

Status
Active
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
study of molecular and protein pathways
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Heart Disease focused on measuring molecular pathways, cardiac remodeling, coronary insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: heart failure patients Exclusion Criteria: patients suffering from infectious diseases and serious infectious diseases

Sites / Locations

  • Fondazione Policlinico Gemelli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Chronic heart failure partecipants

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

Partecipants with pulmonary hypertension

Partecipants with advanced HFrEF

Control Group

Arm 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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Analyze gene expression in patients with cronic heart failure
Identify the most highly expressed genes in the different clinical conditions under investigation.

Full Information

First Posted
February 14, 2023
Last Updated
March 17, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05772754
Brief Title
Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction by New Omics Technologies
Acronym
HFpEF
Official Title
Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction HFpEF by New Omics Technologies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
molecular pathways, cardiac remodeling, coronary insufficiency

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Partecipants with heart failure and pulmonary hypertension
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic heart failure partecipants
Arm Type
Other
Arm 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
Arm Title
Chronic hert faiure and ejection fraction less than 40% at echocardiographic evaluation
Arm Type
Other
Arm 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
Arm Title
Partecipants with pulmonary hypertension
Arm Type
Other
Arm Description
Patients admitted with advanced HFpEF with development of pulmonary hypertension PH-HFpEF
Arm Title
Partecipants with advanced HFrEF
Arm Type
Other
Arm Description
Patients admitted with advanced HFrEF with development of pulmonary hypertension PH-HFrEF
Arm Title
Control Group
Arm Type
Other
Arm Description
12 Controls (CTRL), recruited in the outpatient setting among subjects with cardiovascular disease, in the absence of heart failure
Intervention Type
Genetic
Intervention Name(s)
study of molecular and protein pathways
Other Intervention Name(s)
Analysis of protein profile, Genomics analysis
Intervention Description
42 ml peripheral venous blood sample.
Primary Outcome Measure Information:
Title
The first aim of the study is to identify the protein expression to cardiac remodelling
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Identify interaction variations between protein pathways
Description
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.
Time Frame
6 months
Title
Analyze gene expression in patients with cronic heart failure
Description
Identify the most highly expressed genes in the different clinical conditions under investigation.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: heart failure patients Exclusion Criteria: patients suffering from infectious diseases and serious infectious diseases
Facility Information:
Facility Name
Fondazione Policlinico Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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