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OpenTrials
Completed

NCT Number: NCT03260621

CMR Exercise Stress Testing in HFpEF

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.

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Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Goettingen

Göttingen, 37073, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stress CMR

Diagnostic Test

additional stress CMR to the established clinical diagnostics

Primary outcomes

  1. Cardiovascular magnetic resonance imaging

    Time frame: approx. 1 years

    ventricular and atrial volumes

  2. Cardiovascular magnetic resonance imaging

    Time frame: approx. 1 years

    ventricular and atrial mechanics: strain

  3. Cardiovascular magnetic resonance imaging

    Time frame: approx. 1 years

    quantification of extracellular volume (ECV)/interstitial fibrosis

Other outcomes

  1. Exercise spirometry

    Time frame: approx. 1 years

    maximal oxygen uptake

  2. Exercise spirometry

    Time frame: approx. 1 years

    respiratory quotient

  3. Exercise spirometry

    Time frame: approx. 1 years

    power (watt/kg)

  4. Right heart catheterization

    Time frame: approx. 1 years

    reference for intracardiac pressures: pulmonary artery pressure and pulmonary capillary wedge pressure

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

Cardiovascular Magnetic Resonance Real-time Exercise Stress Testing in Heart Failure With Preserved Ejection Fraction

Acronym: HFpEF-Stress

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 24, 2017
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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