Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-09
Brief Title:
HFPEF-project Heart Failure Phenotyping - Exploring the Fingerprints
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
HFPEF-project Heart Failure Phenotyping - Exploring the Fingerprints Prospective Observational Study Aiming at Detailed Characterization and Deep Phenotyping of Patients With Heart Failure and Preserved Ejection Fraction LVEF40
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With an ageing population the number of patients with heart failure with preserved ejection fraction HFpEF or diastolic heart failure is increasing rapidly This condition is associated with significantly increased morbidity and mortality but effective treatment options that improve prognosis are very limited
Further understanding of the nature and determinants of this disease is needed to develop better treatments of HFpEF and to improve the prognosis and quality of life of these patients
This study will collect a comprehensive prospective dataset of patients with HFpEF and determine which factors influence the prognosis of this patient group
The specific aim is to create an accurate description of the spectrum and subtypes of HFpEF enabling better tools to plan and implement individualised treatment for patients
The main objectives of the study are
to describe and categorize the phenotype of HFpEF patients deep phenotyping using the latest biochemical functional and imaging techniques
identifying factors affecting prognosis and potential new prognostic markers
prospective follow-up of a contemproary cohort of HFpEF patients to assess outcomes such as hospitalisations for heart failure mortality and quality of life
identification of specific or aberrant HFpEF phenotypes for genetic studies
Target population
Patients minimum18 years old with hospitalization for heart failure 1 or 2 cause for hospitalization or outpatients with heart failure AND
Left ventricular ejection fraction LVEF 40 within 12 months prior to or during index hospitalization assessed by ECHO MRI LV-cineangiography or radionuclide imaging AND
Elevated BNPNTproBNP AND
Impaired myocardial relaxation diastolic dysfunction assessed by tissue doppler imaging TDI velocities on ECHO lateral mitral annulus velocity lat E 9cms or septal annulus velocity sept E 8 cms
Both de-novo HF and patients with previously diagnosed HF will be eligible
The study prospective observational study is carried out at Helsinki and Uusimaa Hospital District HUS
Further understanding of the nature and determinants of this disease is needed to develop better treatments of HFpEF and to improve the prognosis and quality of life of these patients
This study will collect a comprehensive prospective dataset of patients with HFpEF and determine which factors influence the prognosis of this patient group
The specific aim is to create an accurate description of the spectrum and subtypes of HFpEF enabling better tools to plan and implement individualised treatment for patients
The main objectives of the study are
to describe and categorize the phenotype of HFpEF patients deep phenotyping using the latest biochemical functional and imaging techniques
identifying factors affecting prognosis and potential new prognostic markers
prospective follow-up of a contemproary cohort of HFpEF patients to assess outcomes such as hospitalisations for heart failure mortality and quality of life
identification of specific or aberrant HFpEF phenotypes for genetic studies
Target population
Patients minimum18 years old with hospitalization for heart failure 1 or 2 cause for hospitalization or outpatients with heart failure AND
Left ventricular ejection fraction LVEF 40 within 12 months prior to or during index hospitalization assessed by ECHO MRI LV-cineangiography or radionuclide imaging AND
Elevated BNPNTproBNP AND
Impaired myocardial relaxation diastolic dysfunction assessed by tissue doppler imaging TDI velocities on ECHO lateral mitral annulus velocity lat E 9cms or septal annulus velocity sept E 8 cms
Both de-novo HF and patients with previously diagnosed HF will be eligible
The study prospective observational study is carried out at Helsinki and Uusimaa Hospital District HUS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: