Exploring heart failure with preserved ejection fraction
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 (LVEF>40%)
This study is trying to gather detailed information about patients with heart failure and preserved ejection fraction to see how different factors affect their treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Helsinki Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT06465043 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect a comprehensive dataset of patients diagnosed with heart failure with preserved ejection fraction (HFpEF). It focuses on deep phenotyping to categorize the spectrum and subtypes of HFpEF, utilizing advanced biochemical and functional assessments. By understanding the determinants influencing prognosis, the study seeks to enhance individualized treatment planning for patients suffering from this condition. The findings could lead to improved management strategies and better outcomes for those affected by HFpEF.
Who should consider this trial
Good fit: Ideal candidates include individuals hospitalized for heart failure or experiencing debilitating dyspnea with a confirmed diagnosis of HFpEF.
Not a fit: Patients over 85 years of age or those with significant aortic valve stenosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with HFpEF.
How similar studies have performed: Other studies have shown promise in understanding HFpEF through similar phenotyping approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 a period of hospitalisation as determined by either cardiac ultrasound, MRI, left ventricular 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) as determined by tissue doppler imaging (TDI: lateral mitral annulus velocity, lat E\' \<9cm/s or septal annulus velocity, sept E\' \<8 cm/s) * Both previously undiagnosed, de-novo heart failure patients and patients admitted to hospital for acute exacerbation of known heart failure will be included in the study. Exclusion Criteria: * Age \>85 years * Significant aortic valve stenosis (AVA ≤1.0 cm2) * Primary (structural) mitral valve disease with grade III-IV insufficiency or significant stenosis (MVA\<1.5 cm2) * Other severe valvular defect (e.g. secondary severe mitral or severe tricuspid insufficiency) * Previous LVEF \< 40% (HFrEF or HF with improved EF) * Recent acute coronary syndrome (\< 3 months) or myocardial infarction with ST elevations (STEMI) within 12 months * Previous open heart surgery (CABG/valvular) or percutaneous valvular interventio * Previously known specific myocardial disease (hypertrophic cardiomyopathy, non-compaction cardiomyopathy (LVNC), right ventricular arrhythmogenic cardiomyopathy (ARVC), cardiac amyloidosis, cardiac sarcoidosis, haemochromatosis) * End-stage renal disease (eGFR \<15 ml/min or dialysis treatment, previous kidney transplantation) * Significant physical disability, mobility limitation, or dependence on another person for assistance (patient is not self-sufficient) limits participation in the study
Where this trial is running
Helsinki
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Johan Lassus, Md.; Ph.D
- Email: johan.lassus@hus.fi
- Phone: +358 50 4284708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.