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Heart Failure With Preserved Ejection FractionPREDICT-HFpEFNCT04894968

Prediction of the Development of Heart Failure With Preserved Ejection Fraction

An observational study of Heart Failure With Preserved Ejection Fraction, run by Heart Center Leipzig - University Hospital at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016
How many people
800 participants
Where
1 siteGermany
Study dates
1 Dec 2018to Nov 2022
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients without evident heart failure with preserved ejection fraction that were included in the prospective cohort study: LIFE-Heart

Who may be able to join

  • At timepoint of inclusion in the LIFE-Heart study normal left ventricular ejection fraction (≥ 50%)
  • At timepoint of inclusion in the LIFE-Heart study normal NT-proBNP (< 125 ng/l)

Who cannot join

  • At timepoint of inclusion in the LIFE-Heart study acute coronary syndrom
  • Troponine elevation above 14 pg/ml as well as coronary intervention, or isolated troponine elevation above 50 pg/ml in the absence of a coronary intervention
  • No troponine elevation but coronary intervention
  • Creatine kinase > 0.41 µmol/l*s and Creatine kinase to Creatine kinase-MB ration >6% or Creatine kinase-MB > 0.82 µmol/l*s
  • At timepoint of inclusion in the LIFE-Heart study missing data on left ventricular ejection fraction
  • At timepoint of inclusion in the LIFE-Heart study missing NT-proBNP measurement
  • At timepoint of inclusion in the LIFE-Heart study missing data on echocardiographic diastolic function and structural alterations of the left ventricle
  • At timepoint of inclusion in the LIFE-Heart study relevant valvular heart disease (including relevant aortic stenosis, mitral- and/or tricuspid regurgitation, congenital heart disease, mitral stenosis)

Trial locations and contacts

1 site in 1 country.

Philipp Lurz, MD, PhD contact

0341865252022

philipp.lurz@medizin.uni-leipzig.de

Germany1 site, 1 recruiting

  • Heart Center Leipzig at Leipzig University

    Leipzig, Saxony, 04289

    Philipp Lurz, MD, PhD, +49341865252022, Philipp.Lurz@medizin.uni-leipzig.de

    Maximilian von Roeder, MD, +49341865252517, maximilian.vonroeder@medizin.uni-leipzig.de

    Recruiting

Other trials in Germany

About this study

Official title: Identifying Predictors for the Development and Uphold of Heart Failure With Preserved Ejection Fraction

The ultimate goal of the PREDICT-HFpEF study is to identify and unravel predictors for the development of heart failure with preserved ejection fraction (HFpEF) in a cohort at increased cardiovascular risk. Patients that were initially included in another prospective cohort study (LIFE-Heart study) and did not show evident heart failure at that timepoint, will be followed-up approximately 7-years after their initial inclusion in the LIFE-Heart study. Patients will be screened for the development of HFpEF and characterized with thorough clinical as well as laboratory assessment. Patients will be classified according to the presence of absence of heart failure and predictors for the development will be identified by using measurements taken at their initial inclusion in the LIFE-Heart study.

Read the detailed description

Heart failure with preserved ejection fraction (HFpEF) is associated with severe morbidtiy and mortality. Yet, little is known about factors leading to the development of HFpEF investigated in a longitudinal fashion. The PREDICT-HFpEF study aims to adress this open question. Patients that were initially included in a large cohort study (LIFE-Heart study) approximately 7-years ago, that underwent thorough clinical, laboratory and echocardiographic assessment, and did not show evidence of heart failure at the present time point will be included in the current study.

Patients will be screened for the development of HFpEF or other forms of heart failure (e.g. heart failure with reduced ejection fraction) and will again undergo thorough clinical, laboratory and echocardiographic assessment. Initially measured biomarkers (including clinical data, lab-charts, ECG recordings and echocardiography) will be used to predict the development of HFpEF in this cohort at cardiovascular risk.

Being tested
Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016
Keywords
Heart failure with preserved ejection fraction, Heart failure, Adiposity, Inflammation
Medical subject headings
Heart Failure, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016Diagnostic test

    Patient will be screened for the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016.

    This requires patients to fulfill all of the four criteria listed below:

    1. Symptoms of heart failure (e.g. dyspnea on extertion)
    2. Preserved ejection fraction (Left ventricular ejection fraction ≥50%
    3. NT-proBNP ≥125 pg/mL
    4. Echocardiographic signs for structural heart disease or diastolic dysfunction (at least one of the criteria below)
    • Left atrial volume index >34 mL/m²
    • Left ventricular mass index ≥115 g/m² for males or ≥95 g/m² for females
    • E/e' ≥13
    • Septal e' <9 cm/s

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure with preserved ejection

    Presence of heart failure with preserved ejection fraction according to the European Society of Cardiology 2016 criteria

    Measured: At timepoint of inclusion

Secondary outcomes (4)

  1. Occurence of major adverse cardiovascular events

    Patients will be followed-up after their inclusion in the PREDICT-HFpEF study for the occurence of major adverse cardiovascular events using regular telephone interviews.

    Measured: 24-months after study inclusion

  2. Changes in vascular status

    Patients vascular status will be screened at study inclusion (e.g. intima media thickness) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study

    Measured: At timepoint of inclusion

  3. Changes in organ function

    Patients liver, as well as renal function as assessed by laboratory status will be screened at study inclusion (e.g. creatinine, bilirubine, Gamma-glutamyltransferase) and will be set in relation to initially assessed vascular status at their initial inclusion in the LIFE-Heart study

    Measured: At timepoint of inclusion

  4. All-cause death

    Patients will be screened on a yearly basis for the occurence of all-cause mortality

    Measured: Yearly, after study enrollment up to ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start1 Dec 2018
  3. Primary completionMay 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

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
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894968
Sponsor's protocol ID
PREDICT-HFpEFv1
Acronym
PREDICT-HFpEF
Status last verified
Mar 2022
First submitted
17 May 2021
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lucke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.

    PubMed 27081022

  • Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.

    PubMed 29449367

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Preserved Ejection Fraction, run by Heart Center Leipzig - University Hospital at 1 site in Germany.

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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Mar 2022. 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 Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Philipp Lurz, MD, PhD (0341865252022, philipp.lurz@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure with preserved ejection (time frame: At timepoint of inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04894968, which also lists 2 linked publications.

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 17 Mar 2022.

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