Heart Failure with Preserved Ejection FractionNCT06465043
HFPEF-project: Heart Failure Phenotyping - Exploring the Fingerprints
An observational study of Heart Failure with Preserved Ejection Fraction, run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure with Preserved Ejection Fraction
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- 23 Aug 2024to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HFpEF hospitalised or attending cardiology outpatient clinic at Helsinki and Uusimaa Hospital District
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Johan Lassus, M.D, 358 50 5765781, johan.lassus@hus.fi
About this study
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 (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.
Read more
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).
- Keywords
- HFpEF, iCPET, heart failure, invasive hemodynamics
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
All- cause mortality
Death from any cause
Measured: 1 year
Secondary outcomes (3)
Heart Failure Hospitalisation
Rate of hospitalisation for worsening heart failure
Measured: 12 months
All cause mortality
Death from any cause
Measured: 5 years
Cardiovascular mortality
Death from cardiovascular causes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start23 Aug 2024
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Aarne Koskelo Foundation, Finnish Foundation for Cardiovascular Research
- Responsible party
- Principal investigator, Johan Lassus, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465043
- Sponsor's protocol ID
- HUS/628/2024
- Status last verified
- Sep 2024
- First submitted
- 9 May 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (LVEF>40%)
- ClinicalTrials.gov ID
- NCT06465043
- Acronym / sponsor ID
- HUS/628/2024
- Keywords
- HFpEF, iCPET, heart failure, invasive hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Aarne Koskelo Foundation, Finnish Foundation for Cardiovascular Research
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HFpEF hospitalised or attending cardiology outpatient clinic at Helsinki and Uusimaa Hospital District
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All- cause mortality
Time frame: 1 year
Death from any cause
3 secondary outcomes
Heart Failure Hospitalisation
Time frame: 12 months
All cause mortality
Time frame: 5 years
Cardiovascular mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure with Preserved Ejection Fraction, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Lassus, Md.; Ph.D (+358 50 4284708, johan.lassus@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All- cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.