NCT03260621

Brief Summary

Patients of the University Hospital Göttingen with echocardiographic signs for diastolic heart failure and indication for right heart catheterisation will undergo additional diagnostic testing with CMR including exercise stress for detailed evaluation of diastolic dysfunction and tissue characterisation correlating the results with well-established clinical standards.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

August 10, 2017

Last Update Submit

November 13, 2020

Conditions

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (3)

  • Cardiovascular magnetic resonance imaging

    ventricular and atrial volumes

    approx. 1 years

  • Cardiovascular magnetic resonance imaging

    ventricular and atrial mechanics: strain

    approx. 1 years

  • Cardiovascular magnetic resonance imaging

    quantification of extracellular volume (ECV)/interstitial fibrosis

    approx. 1 years

Other Outcomes (4)

  • Exercise spirometry

    approx. 1 years

  • Exercise spirometry

    approx. 1 years

  • Exercise spirometry

    approx. 1 years

  • +1 more other outcomes

Study Arms (2)

echocardiographic increase in left atrial pressure

OTHER
Diagnostic Test: stress CMR

echocardiographic no increase in left atrial pressure

OTHER
Diagnostic Test: stress CMR

Interventions

stress CMRDIAGNOSTIC_TEST

additional stress CMR to the established clinical diagnostics

echocardiographic increase in left atrial pressureechocardiographic no increase in left atrial pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with dyspnoea under stress, echocardiographic criteria for diastolic dysfunction (E/E'\>8) and clinical indication for right heart catheterisation

You may not qualify if:

  • arrhythmia (brady- or tachycardic)
  • bronchial asthma (allergic)
  • incompliant patient
  • pacemaker, ICD, non MRI-capable devices
  • inability to use the ergometer in the MRI
  • haemodynamic relevant valvular heart disease
  • pulmonary disease (vital capacity or forced expiratory flow \<80% of healthy control)
  • angina pectoris
  • post cardiac infarction
  • anaemia (Hb \<12 g/dl)
  • uncontrollable hypertension (\>150 mmHg systolic or \>100 mmHg diastolic)
  • age \<18 years
  • pregnancy
  • claustrophobia
  • renal insufficiency
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Goettingen

Göttingen, 37073, Germany

Location

Related Publications (9)

  • Backhaus SJ, Schulz A, Lange T, Rosel SF, Schmidt-Schweda LS, Kutty S, Kowallick JT, Treiber J, Rolf A, Sossalla S, Hasenfuss G, Schuster A. Insights from serial cardiovascular magnetic resonance imaging show early progress in diastolic dysfunction relates to impaired right ventricular deformation. Sci Rep. 2025 Feb 3;15(1):4090. doi: 10.1038/s41598-025-87032-5.

    PMID: 39900615DERIVED

  • Schulz A, Schellinger IN, Backhaus SJ, Adler AS, Lange T, Evertz R, Kowallick JT, Hoffmann A, Matek C, Tsao PS, Hasenfuss G, Raaz U, Schuster A. Association of Cardiac MRI-derived Aortic Stiffness with Early Stages and Progression of Heart Failure with Preserved Ejection Fraction. Radiol Cardiothorac Imaging. 2024 Aug;6(4):e230344. doi: 10.1148/ryct.230344.

    PMID: 39145733DERIVED

  • Backhaus SJ, Nasopoulou A, Lange T, Schulz A, Evertz R, Kowallick JT, Hasenfuss G, Lamata P, Schuster A. Left Atrial Roof Enlargement Is a Distinct Feature of Heart Failure With Preserved Ejection Fraction. Circ Cardiovasc Imaging. 2024 Jul;17(7):e016424. doi: 10.1161/CIRCIMAGING.123.016424. Epub 2024 Jul 16.

    PMID: 39012942DERIVED

  • Backhaus SJ, Schulz A, Lange T, Evertz R, Kowallick JT, Hasenfuss G, Schuster A. Rest and exercise-stress estimated pulmonary capillary wedge pressure using real-time free-breathing cardiovascular magnetic resonance imaging. J Cardiovasc Magn Reson. 2024 Summer;26(1):101032. doi: 10.1016/j.jocmr.2024.101032. Epub 2024 Feb 29.

    PMID: 38431079DERIVED

  • Backhaus SJ, Schulz A, Lange T, Schmidt-Schweda LS, Evertz R, Kowallick J, Hasenfuss G, Schuster A. Real-time cardiovascular magnetic resonance imaging for non-invasive characterisation of heart failure with preserved ejection fraction: final outcomes of the HFpEF stress trial. Clin Res Cardiol. 2024 Mar;113(3):496-508. doi: 10.1007/s00392-023-02363-5. Epub 2024 Jan 3.

    PMID: 38170248DERIVED

  • Backhaus SJ, Lange T, Schulz A, Evertz R, Frey SM, Hasenfuss G, Schuster A. Cardiovascular magnetic resonance rest and exercise-stress left atrioventricular coupling index to detect diastolic dysfunction. Am J Physiol Heart Circ Physiol. 2023 May 1;324(5):H686-H695. doi: 10.1152/ajpheart.00081.2023. Epub 2023 Mar 10.

    PMID: 36897745DERIVED

  • Schuster A, Schulz A, Lange T, Evertz R, Hartmann F, Kowallick JT, Hellenkamp K, Uecker M, Seidler T, Hasenfuss G, Backhaus SJ. Concomitant latent pulmonary vascular disease leads to impaired global cardiac performance in heart failure with preserved ejection fraction. Eur J Heart Fail. 2023 Mar;25(3):322-331. doi: 10.1002/ejhf.2781. Epub 2023 Mar 2.

    PMID: 36691723DERIVED

  • Backhaus SJ, Uzun H, Rosel SF, Schulz A, Lange T, Crawley RJ, Evertz R, Hasenfuss G, Schuster A. Hemodynamic force assessment by cardiovascular magnetic resonance in HFpEF: A case-control substudy from the HFpEF stress trial. EBioMedicine. 2022 Dec;86:104334. doi: 10.1016/j.ebiom.2022.104334. Epub 2022 Nov 21.

    PMID: 36423376DERIVED

  • Backhaus SJ, Lange T, George EF, Hellenkamp K, Gertz RJ, Billing M, Wachter R, Steinmetz M, Kutty S, Raaz U, Lotz J, Friede T, Uecker M, Hasenfuss G, Seidler T, Schuster A. Exercise Stress Real-Time Cardiac Magnetic Resonance Imaging for Noninvasive Characterization of Heart Failure With Preserved Ejection Fraction: The HFpEF-Stress Trial. Circulation. 2021 Apr 13;143(15):1484-1498. doi: 10.1161/CIRCULATIONAHA.120.051542. Epub 2021 Jan 21.

    PMID: 33472397DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Andreas Schuster, MD, PhD

    University of Göttingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 24, 2017

Study Start

August 16, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

The data acquired within the current study will be available via the german centre for cardiovascular research (DZHK) to researchers who successfully applied to undertake additional scientific studies based on DZHK data.

Locations

DE(1)