Actively Recruiting
HFPEF-project: Heart Failure Phenotyping - Exploring the Fingerprints
Led by University of Helsinki · Updated on 2024-12-18
300
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
Sponsors
U
University of Helsinki
Lead Sponsor
A
Aarne Koskelo Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 BNP/NTproBNP AND * Impaired myocardial relaxation (diastolic dysfunction) assessed by tissue doppler imaging (TDI) velocities on ECHO: lateral mitral annulus velocity (lat E') \>9cm/s or septal annulus velocity (sept E') \>8 cm/s * 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).
CONDITIONS
Official Title
HFPEF-project: Heart Failure Phenotyping - Exploring the Fingerprints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalisation for heart failure or debilitating dyspnoea (NYHA II-IV) and a diagnosis of HFpEF
- Left ventricular ejection fraction (LVEF) >40% in the preceding 12 months or during hospitalisation as determined by cardiac ultrasound, MRI, echocardiography, or isotope imaging
- NTproBNP >300 pg/ml (or BNP >100 pg/ml) during hospitalisation or NTproBNP >125 pg/ml in outpatients
- Impaired myocardial relaxation (diastolic dysfunction) shown by tissue doppler imaging with lat E' <9cm/s or sept E' <8 cm/s
- Both newly diagnosed heart failure patients and patients admitted for acute worsening of known heart failure are eligible
You will not qualify if you...
- Age over 85 years
- Significant aortic valve stenosis (area ≤1.0 cm2)
- Primary structural mitral valve disease with severe insufficiency or significant stenosis (area <1.5 cm2)
- Other severe valvular defects such as secondary severe mitral or severe tricuspid insufficiency
- Previous LVEF less than 40% (heart failure with reduced ejection fraction or improved EF)
- Recent acute coronary syndrome (<3 months) or myocardial infarction with ST elevations within 12 months
- Previous open heart surgery (CABG/valvular) or percutaneous valvular intervention
- Known specific myocardial diseases including hypertrophic cardiomyopathy, non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, cardiac amyloidosis, cardiac sarcoidosis, or haemochromatosis
- End-stage renal disease with eGFR <15 ml/min, dialysis, or previous kidney transplant
- Significant physical disability or dependence on others limiting self-sufficiency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
Research Team
J
Johan Lassus, Md.; Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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