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Heart Failure With Normal Ejection FractionDECIPHER-HFpEFNCT03251183

Validation of CMR Against Invasive Haemodynamics in Patients With HFpEF

An observational study of Heart Failure With Normal Ejection Fraction, run by Goethe University at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year and 50% mortality at 5 years. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Comprehensive Cardiovascular magnetic resonance (CMR), Blood sampling and TTE (EchoErgo)
How many people
185 participants
Where
7 sitesGermany
Study dates
14 Jan 2018to 31 Dec 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 with diagnostic criteria for HFpEF, age/gender matched controls and healty volunteers

Who may be able to join

  • Ability to provide informed consent
  • Typical HF symptoms (NYHA stage II-III) within the last 6 months
  • EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement)
  • Echocardiographic evidence of increased left ventricular filling pressures
  • E/E'sep >15 OR E/E'lat >12 OR Av E/E' >13 OR
  • E/E' >9 AND left atrial (LA) volume >34 ml/m2 OR systolic pulmonary artery pressure (PAsys): >35 mmHg;
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  • Indication for invasive hemodynamic work-up
  • Unclear aetiology of heart failure
  • Adults: age >18 years
  • Ability to provide informed consent
  • No current or history of symptoms, signs or therapy for heart disease
  • EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement)
  • Adults: age >18 years
  • Ability to provide informed consent
  • No current or history of symptoms, signs or therapy for heart disease
  • EF ≥ 50 % with absence of structural heart disease on echocardiography

Who cannot join

  • Patients unable or unwilling to provide informed consent
  • High likelihood of non-diagnostic PV loops of MR imaging (e.g. atrial fibrillation or high rate of premature ventricular contraction (PVC) (> 10 ventricular Extrasystole (VES)/minute), > 150 kg body weight, inability to lie flat or still)
  • Contraindication for invasive work-up (allergy to contrast agent, severe renal insufficiency with estimated glomerular filtration rate (eGRF) <30 ml/min)
  • Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia)
  • Previous medical history of EF <45%
  • Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)
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  • Age-gender matched controls:
  • Patients unable or unwilling to provide informed consent
  • High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)
  • Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia, severe renal insufficiency with eGRF <30 ml/min))
  • Previous medical history of EF <45%
  • Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)
  • Healthy volunteers:
  • Contraindications for an MR study
  • High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)
  • Subjects unable or unwilling to provide informed consent
  • EF <50% in patient history
  • Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Kerckhoff Klinik

    Bad Nauheim

  • Charite Centrum Herz-, Kreislauf- und Gefäßmedizin

    Berlin

  • University Hospital Frankfurt

    Frankfurt am Main, Hesse, 60590

  • University Hospital Göttingen

    Göttingen

  • University Hospital

    Heidelberg

  • Herzzentrum Leipzig

    Leipzig

  • Uniersity Hospital Mainz

    Mainz

Other trials in Germany

About this study

Official title: Validation of Cardiovascular Magnetic Resonance Against Invasive Haemodynamics in Patients With Heart Failure With Preserved Ejection Fraction (DECIPHER HFpEF)

Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no non-invasive measure provides a clear diagnosis.

Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation of heart structure and function. New CMR parameters offer the possibility to describe the underlying pathological and physiological changes associated with HFpEF.

The investigators propose to undertake the first systematic comparison between a CMR protocol and invasive haemodynamics as the best possible gold standard, as well as define the histopathological drivers in myocardial biopsies. The investigators will also examine the relations with tissue and serological biomarkers implicated in HFpEF and the role with standard and novel parameters by echocardiography. If successful, this study will provide tools for a reliable and accurate non-invasive characterization of patients with HFpEF, supporting the diagnosis and grading the severity of disease. This study will provide a reference basis for future diagnostic algorithms in HFpEF, both, for CMR and echocardiography, but also for their relative value in comparison to blood markers or invasive testing. In addition to a new pathway to acess the effects of current and novel therapeutic interventions, the investigators see the greatest potential in identifying a disease stage where the myocardial injury may be reversible.

Being tested
Comprehensive Cardiovascular magnetic resonance (CMR), Blood sampling, TTE (EchoErgo), Invasive pressure-volume (PV) Loops, Left ventricular (LV) biopsy

What participants receive

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

  • Comprehensive Cardiovascular magnetic resonance (CMR)Diagnostic test

    Cardiovascular magnetic resonance (CMR) provides non-invasive, radiation-free and in-depth evaluation of myocardial structure and function. In addition to established tools for assessment of cardiac volume, mass, function and regional myocardial scar with late Gadolinium enhancement (LGE), several novel quantitative CMR parameters will be assessed including T1-mapping or fully quantitative perfusion Imaging.

  • Blood samplingDiagnostic test

    Blood samples will eventually be analysed for markers related to heart failure (BNP/NT)-pro-BNP, myocardial inflammation and fibrosis (cytokine profiling, Galectin-3, Procollagen Type I and III, hsCRP). Whole blood will be frozen for DNA isolation and genome analysis. Peripheral blood mononuclear cells will be isolated by Ficoll in a subset of patients and will be used for RNA isolation allowing RNA-seq or reverse transcription (RT) - polymerase chain reaction (PCR) analysis.

  • TTE (EchoErgo)Diagnostic test

    Measurements will include cavity dimensions, flow velocities, myocardial motion velocity and strain as well as for change of parameters during ergometric stress.

  • Invasive pressure-volume (PV) LoopsDiagnostic test

    Multiple parameters (including EDPVR, ESPVR, dp/dt min, Tau, Ea) will be derived from the various PV loop assessments and additional relevant parameters will be calculated. Right ventricular and pulmonary pressures including pulmonary vascular resistance will be measured with Swan-Ganz catheters using right venous femoral approach.

  • Left ventricular (LV) biopsyDiagnostic test

    A set of myocardial biopsies for each patient will be stained with Masson Trichrome for qualitative and quantitative assessment of the collagen volume fraction; fat droplets will be identified by red oil staining, Congo Red for amyloid immunohistology will be used to determine total leukocytes (CD45), T-cells (CD3) and monocytes/macrophages (CD68).

    A second set of biopsies will be frozen immediately and stored at -80°. Western blot analysis will be performed to determine alterations at the myofilament level including titin isoform composition and phosphorylation status.

Study groups in NCT03251183
Study groupRoleWhat they receive
Main groupBlood sampling Comprehensive Cardiovascular magnetic resonance (CMR) Transthoracic echocardiography (TTE) (EchoErgo) Invasive pressure-volume (PV) Loops Left ventricular (LV) biopsy
Receives: Diagnostic Test: Comprehensive Cardiovascular magnetic resonance (CMR); Diagnostic Test: Blood sampling; Diagnostic Test: TTE (EchoErgo); Diagnostic Test: Invasive pressure-volume (PV) Loops; Diagnostic Test: Left ventricular (LV) biopsy
Reproducibility groupStress-perfusion Cardiovascular magnetic resonance (CMR)
Receives: Diagnostic Test: Comprehensive Cardiovascular magnetic resonance (CMR); Diagnostic Test: Blood sampling
Age/gender matched control groupBlood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)
Receives: Diagnostic Test: Comprehensive Cardiovascular magnetic resonance (CMR); Diagnostic Test: Blood sampling; Diagnostic Test: TTE (EchoErgo)
Healthy volunteersBlood sampling Stress-perfusion Cardiovascular magnetic resonance (CMR) TTE (EchoErgo)
Receives: Diagnostic Test: Comprehensive Cardiovascular magnetic resonance (CMR); Diagnostic Test: Blood sampling; Diagnostic Test: TTE (EchoErgo)

What is being measured

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

  1. Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR).

    Using a multivariable regression analysis and a respective F test.

    Measured: up to 4 weeks. No follow up is planned.

Secondary outcomes (7)

  1. Association between CMR T1-mapping and biopsy results.

    Using suitable regression and correlation Analysis.

    Measured: up to 4 weeks. No follow up is planned.

  2. Association between CMR flow echocardiographic flow

    Using suitable regression and correlation Analysis.

    Measured: up to 4 weeks. No follow up is planned.

  3. Association between a model for diastolic function based on CMR with a model of diastolic function based on echocardiography

    Using suitable regression and correlation Analysis.

    Measured: up to 4 weeks. No follow up is planned.

  4. Association between CMR function and echocardiographic function

    Using suitable regression and correlation Analysis.

    Measured: up to 4 weeks. No follow up is planned.

  5. Discriminatory capacity of a multivariate model of invasive and a multivariate model of non-invasive variables.

    Using the patient and control groups with comparative ROC analysis and DeLong tests.

    Measured: up to 4 weeks. No follow up is planned.

  6. Reproducibility at one site.

    Using respective intra-class correlations in the groups with multiple measurements.

    Measured: up to 4 weeks. No follow up is planned.

  7. Variability between the different sites.

    Using respective intra-class correlations in the groups with multiple measurements.

    Measured: up to 4 weeks. No follow up is planned.

Timeline

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

  1. First posted16 Aug 2017
  2. Study start14 Jan 2018
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

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
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03251183
Sponsor's protocol ID
Protocol_ Version 1 20170225
Acronym
DECIPHER-HFpEF
Status last verified
Mar 2023
First submitted
14 May 2017
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be shared with other researchers within the German Centre for Cardiovascular Research (DZHK) via the Use and Access Rules

Publications

  • Nagel E, Wenzel P, Seidler T, Rommel KP, Andre F, Kelle S, Rolf A, Vasa-Nicotera M, Herrmann E, Escher F, Hoffmann J, Rademakers F, Lurz P, Puntmann VO; Decipher HFpEF Study Group. Myocardial Tissue Characterization by CMR Captures Mechanistic Severity Beyond Filling Pressure in HFpEF: The Multicenter DECIPHER HFpEF Study. JACC Cardiovasc Imaging. 2026 Sep 16:S1936-878X(26)00373-6. doi: 10.1016/j.jcmg.2026.07.012. Online ahead of print.

    PubMed 42762217

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Normal Ejection Fraction, run by Goethe University at 7 sites 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 16 inclusion and 18 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: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR). (time frame: up to 4 weeks. No follow up is planned.). 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 NCT03251183, which also lists 1 linked publication.

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 10 Mar 2023.

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