CMR Exercise Stress Testing in HFpEF

NCT ID: NCT03260621

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diastolic Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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echocardiographic increase in left atrial pressure

Group Type OTHER

stress CMR

Intervention Type DIAGNOSTIC_TEST

additional stress CMR to the established clinical diagnostics

echocardiographic no increase in left atrial pressure

Group Type OTHER

stress CMR

Intervention Type DIAGNOSTIC_TEST

additional stress CMR to the established clinical diagnostics

Interventions

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stress CMR

additional stress CMR to the established clinical diagnostics

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
* allergic to gadolinium based contrast agents
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

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Andreas Schuster

PD Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Schuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Göttingen

Locations

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University Hospital Goettingen

Göttingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39900615 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39145733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39012942 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38431079 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38170248 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36897745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36691723 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36423376 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33472397 (View on PubMed)

Other Identifiers

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35/8/15

Identifier Type: -

Identifier Source: org_study_id