HFPEF-project: Heart Failure Phenotyping - Exploring the Fingerprints (HFpEF-project)

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%)

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure with Preserved Ejection Fraction

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Johan Lassus, Md.; Ph.D; Phone Number: +358 50 4284708; Email: johan.lassus@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki university hospital
    • Contact: Johan Lassus, M.D; Phone Number: 358 50 5765781; Email: johan.lassus@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HFpEF hospitalised or attending cardiology outpatient clinic at Helsinki and Uusimaa Hospital District

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All- cause mortality	Death from any cause	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Death from any cause	5 years
Cardiovascular mortality	Death from cardiovascular causes	1 year
Heart Failure Hospitalisation	Rate of hospitalisation for worsening heart failure	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	6-minute walking test (walk distance in meters)	6 months

Collaborators and Investigators

• Sponsor: University of Helsinki
• Collaborators: Finnish Foundation for Cardiovascular Research; Aarne Koskelo Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; HFpEF; iCPET; invasive hemodynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HUS/628/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No