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

March 17, 2023 updated by: Liuzzo Giovanna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Fondazione Policlinico Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • heart failure patients

Exclusion Criteria:

  • patients suffering from infectious diseases and serious infectious diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Genetic: study of molecular and protein pathways
42 ml peripheral venous blood sample.
Other Names:
  • Analysis of protein profile
  • Genomics analysis
Other: 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
Genetic: study of molecular and protein pathways
42 ml peripheral venous blood sample.
Other Names:
  • Analysis of protein profile
  • Genomics analysis
Other: Partecipants with pulmonary hypertension
Patients admitted with advanced HFpEF with development of pulmonary hypertension PH-HFpEF
Genetic: study of molecular and protein pathways
42 ml peripheral venous blood sample.
Other Names:
  • Analysis of protein profile
  • Genomics analysis
Other: Partecipants with advanced HFrEF
Patients admitted with advanced HFrEF with development of pulmonary hypertension PH-HFrEF
Genetic: study of molecular and protein pathways
42 ml peripheral venous blood sample.
Other Names:
  • Analysis of protein profile
  • Genomics analysis
Other: Control Group
12 Controls (CTRL), recruited in the outpatient setting among subjects with cardiovascular disease, in the absence of heart failure
Genetic: study of molecular and protein pathways
42 ml peripheral venous blood sample.
Other Names:
  • Analysis of protein profile
  • Genomics analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The first aim of the study is to identify the protein expression to cardiac remodelling
Time Frame: 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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify interaction variations between protein pathways
Time Frame: 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.
6 months
Analyze gene expression in patients with cronic heart failure
Time Frame: 6 months
Identify the most highly expressed genes in the different clinical conditions under investigation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

July 20, 2021

Study Completion (Anticipated)

December 16, 2024

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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