NCT05772754|UnknownEarly Phase 1
Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction by New Omics Technologies
HFpEF
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HFpEF
Sponsor study identifier
interventional
60
1 country
1
Study Start
December 18, 2020
Actual (reported)Primary Completion
July 20, 2021
Actual (reported)Study Completion
December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2020
Actual (reported)July 20, 2021
Actual (reported)February 14, 2023
Actual (reported)March 16, 2023
Actual (reported)December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Identify interaction variations between protein pathways
6 months
Analyze gene expression in patients with cronic heart failure
6 months
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
42 ml peripheral venous blood sample.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fondazione Policlinico Gemelli
Roma, 00168, Italy
60 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2023
First Posted
March 16, 2023
Study Start
December 18, 2020
Actual (reported)Cardiovascular Effects of Sporting Events
The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
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
Contact the study team to confirm eligibility.
Primary Completion
July 20, 2021
Actual (reported)Study Completion
December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 20, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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