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Dyspnea Assessment in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773991
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Western Ontario, Canada
Western University, Canada
Information provided by (Responsible Party):
Chris McIntyre, Lawson Health Research Institute

Brief Summary:
Shortness of breath is very common among patients on dialysis for kidney failure; however, its causes are often not understood. This study will explore the lungs and the heart of these patients to determine the causes of shortness of breath. The amount of salt in the body tissues, which tends to accumulate in dialysis patients and can also cause shortness of breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and x-rays to take images of the body interior will be employed; in addition, breathing tests, questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited and have two visits: one at the beginning of the study and one year later to observe any changes in the lungs, heart and salt accumulation over time.

Condition or disease Intervention/treatment
Dyspnea; Uremic End Stage Renal Disease Chronic Lung Disease Chronic Heart Disease Hemodialysis-Induced Symptom Sodium Excess Diagnostic Test: Lung MRI Diagnostic Test: Sodium MRI Diagnostic Test: Chest CT Diagnostic Test: Echocardiography Diagnostic Test: Fractional Exhaled Nitric Oxide Diagnostic Test: Pulmonary Function Tests Diagnostic Test: Blood Sampling Diagnostic Test: Six-Minute Walk Test Diagnostic Test: Dyspnea Questionnaires

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Assessment of Dyspnea, Cardiopulmonary Structure and Function in Chronic Hemodialysis Patients
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Maintenance Hemodialysis Patients

Patients on chronic hemodialysis therapy due to end-stage renal disease.

  • Proton Lung MRI
  • Sodium MRI of the leg
  • Chest CT
  • Transthoracic Echocardiography
  • Fractional Exhaled Nitric Oxide
  • Six-Minute Walk Test
  • Pulmonary Function Tests
  • Blood sampling
  • Self-administered dyspnea questionnaires
Diagnostic Test: Lung MRI
Proton Lung Magnetic Resonance Imaging

Diagnostic Test: Sodium MRI
Sodium Soft Tissue Magnetic Resonance Imaging

Diagnostic Test: Chest CT
High-resolution Quantitative Chest CT

Diagnostic Test: Echocardiography
Transthoracic 2D Speckle-Tracking Echocardiography

Diagnostic Test: Fractional Exhaled Nitric Oxide
Fractional Exhaled Nitric Oxide testing

Diagnostic Test: Pulmonary Function Tests
Spirometry and Plethysmography

Diagnostic Test: Blood Sampling
Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins

Diagnostic Test: Six-Minute Walk Test
Six-Minute Walk Test

Diagnostic Test: Dyspnea Questionnaires
Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale




Primary Outcome Measures :
  1. Baseline Modified Medical Research Council scale score. [ Time Frame: Baseline ]
    Baseline dyspnea measured by Modified Medical Research Council scale. 0-4 from lowest (no dyspnea) to highest (most severe dyspnea).

  2. Baseline University of California, San Diego Shortness of Breath Questionnaire score. [ Time Frame: Baseline ]

    Baseline dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire.

    0-120 from lowest (no dyspnea) to highest (most severe dyspnea).


  3. Baseline pulmonary artery diameter. [ Time Frame: Baseline ]
    Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.

  4. Baseline lung total blood vessel volume. [ Time Frame: Baseline ]
    Baseline lung total blood vessel volume in ml by chest Computed Tomography.

  5. Baseline lung total airway count. [ Time Frame: Baseline ]
    Baseline lung total airway count by chest Computed Tomography.

  6. Baseline lung low attenuation area. [ Time Frame: Baseline ]
    Baseline lung low attenuation area by chest Computed Tomography.

  7. Baseline lung water content. [ Time Frame: Baseline ]
    Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.

  8. Baseline soft tissue sodium content. [ Time Frame: Baseline ]
    Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.


Secondary Outcome Measures :
  1. One year changes in Modified Medical Research Council scale score. [ Time Frame: Baseline and one year ]

    Comparison of dyspnea measured by Modified Medical Research Council scale at one year versus baseline.

    0-4 from lowest (no dyspnea) to highest (most severe dyspnea).


  2. Correlation between baseline modified Medical Research Council scale score and one year morbidity. [ Time Frame: Baseline and one year ]
    One year morbidity risk by modified Medical Research Council scale baseline score.

  3. Correlation between baseline modified Medical Research Council scale score and one year mortality. [ Time Frame: Baseline and one year ]
    One year mortality risk by modified Medical Research Council scale baseline score.

  4. Correlation between modified Medical Research Council scale score and soft tissue sodium content. [ Time Frame: Baseline and one year ]
    Correlation coefficient between soft tissue sodium content (mmol/L) and modified Medical Research Council scale score.

  5. Correlation between modified Medical Research Council scale score and pulmonary artery diameter. [ Time Frame: Baseline and one year ]
    Correlation coefficient between modified Medical Research Council scale score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.

  6. Correlation between modified Medical Research Council scale score and lung total blood vessel volume. [ Time Frame: Baseline and one year ]
    Correlation coefficient between modified Medical Research Council scale score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.

  7. Correlation between modified Medical Research Council scale score and lung total airway count. [ Time Frame: Baseline and one year ]
    Correlation coefficient between modified Medical Research Council scale score and lung total airway count, measured by chest Computed Tomography.

  8. Correlation between modified Medical Research Council scale score and lung low attenuation areas. [ Time Frame: Baseline and one year ]
    Correlation coefficient between modified Medical Research Council scale score and lung low attenuation areas, measured by chest Computed Tomography.

  9. Correlation between modified Medical Research Council scale score and lung total water content. [ Time Frame: Baseline and one year ]
    Correlation coefficient between modified Medical Research Council scale score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.

  10. One year changes in University of California, San Diego Shortness of Breath Questionnaire score. [ Time Frame: Baseline and one year ]

    Comparison of dyspnea measured by University of California, San Diego Shortness of Breath Questionnaire at one year versus baseline.

    0-120 from lowest (no dyspnea) to highest (most severe dyspnea).


  11. Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year morbidity. [ Time Frame: Baseline and one year ]
    One year morbidity risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.

  12. Correlation between baseline University of California, San Diego Shortness of Breath Questionnaire score and one year mortality. [ Time Frame: Baseline and one year ]
    One year mortality risk by University of California, San Diego Shortness of Breath Questionnaire baseline score.

  13. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter. [ Time Frame: Baseline and one year ]
    Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and pulmonary artery diameter (in millimeters), measured by chest Computed Tomography.

  14. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and soft tissue sodium content. [ Time Frame: Baseline and one year ]
    Correlation coefficient between soft tissue sodium content (mmol/L) and University of California, San Diego Shortness of Breath Questionnaire score.

  15. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume. [ Time Frame: Baseline and one year ]
    Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total blood vessel volume (in milliliters), measured by chest Computed Tomography.

  16. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count. [ Time Frame: Baseline and one year ]
    Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total airway count, measured by chest Computed Tomography.

  17. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas. [ Time Frame: Baseline and one year ]
    Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung low attenuation areas, measured by chest Computed Tomography.

  18. Correlation between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content. [ Time Frame: Baseline and one year ]
    Correlation coefficient between University of California, San Diego Shortness of Breath Questionnaire score and lung total water content (in arbitrary units), measured by proton Magnetic Resonance Imaging.

  19. One year changes in lung total blood vessel volume. [ Time Frame: Baseline and one year ]
    Comparison of lung total blood vessel volume (in milliliters) at one year versus baseline, measured by chest Computed Tomography.

  20. One year changes in lung total airway count. [ Time Frame: Baseline and one year ]
    Comparison of lung total airway count at one year versus baseline, measured by chest Computed Tomography.

  21. One year changes in lung water content. [ Time Frame: Baseline and one year ]
    Comparison of lung water content (in arbitrary units) at one year versus baseline, measured by proton Magnetic Resonance Imaging.

  22. One year changes in lung low attenuation areas. [ Time Frame: Baseline and one year ]
    Comparison of lung low attenuation areas at one year versus baseline, measured by chest Computed Tomography.

  23. One year changes in pulmonary artery diameter. [ Time Frame: Baseline and one year ]
    Comparison of pulmonary artery diameter (in millimeters) at one year versus baseline, measured by chest Computed Tomography.

  24. Baseline pulmonary artery systolic pressure. [ Time Frame: Baseline ]
    Baseline pulmonary artery systolic pressure (in mmHg), measured by transthoracic doppler echocardiography.

  25. One year changes in pulmonary artery systolic pressure. [ Time Frame: Baseline and one year ]
    Comparison of pulmonary artery systolic pressure in mmHg at one year versus baseline, measured by transthoracic doppler echocardiography.

  26. Baseline fractional exhaled nitric oxide. [ Time Frame: Baseline ]
    Baseline fractional exhaled nitric oxide measured (in parts per billion).

  27. One year changes in fractional exhaled nitric oxide. [ Time Frame: Baseline and one year ]
    Comparison of fractional exhaled nitric oxide measured (in parts per billion) at one year versus baseline.

  28. Baseline forced expiratory volume at one second/forced vital capacity ratio. [ Time Frame: Baseline ]
    Baseline forced expiratory volume at one second/forced vital capacity ratio by pulmonary function tests.

  29. One year changes in forced expiratory volume at one second/forced vital capacity ratio. [ Time Frame: Baseline and one year ]
    Comparison of forced expiratory volume at one second/forced vital capacity ratio at one year versus baseline, by pulmonary function tests.

  30. Baseline diffusing capacity of the lung for carbon monoxide. [ Time Frame: Baseline ]
    Baseline diffusing capacity of the lung for carbon monoxide (in ml/min/kPa), by pulmonary function tests.

  31. One year changes in diffusing capacity of the lung for carbon monoxide. [ Time Frame: Baseline and one year ]
    Comparison of diffusing capacity of the lung for carbon monoxide (in ml/min/kPa) at one year versus baseline, by pulmonary function tests

  32. Baseline six minute walk distance. [ Time Frame: Baseline ]
    Baseline six minute walk distance (in meters) measured by six minute walk test.

  33. One year changes in six minute walk distance. [ Time Frame: Baseline and one year ]
    Comparison of six minute walk distance (in meters) at one year versus baseline, measured by six minute walk test.

  34. One year changes in soft tissue sodium content. [ Time Frame: Baseline and one year ]
    Comparison of soft tissue sodium content (in mmol/L) at one year versus baseline, measured by sodium Magnetic Resonance Imaging.


Biospecimen Retention:   Samples Without DNA
Plasma and serum.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients for this trial will be recruited from incident and prevalent hemodialysis patients receiving care for their kidney disease from the Dialysis Service at London Health Sciences Centre, London Ontario. Up to 20 eligible patients will be recruited.
Criteria

Inclusion Criteria:

  • Age equal to or greater than 18 years.
  • Dialysis vintage equal to or greater than 3 months.

Exclusion Criteria

  • Smoking history of more than 10 packs/year.
  • Active tobacco and/or cannabis smoking.
  • Diagnosed chronic pulmonary disease.
  • Severe heart failure (NYHA class IV)
  • Active infection (including tuberculosis) or malignancy.
  • Pregnancy.
  • Inability to give consent or understand written information.
  • Peripheral oxygen saturation (by pulse oxymetry) dropping below 80% when performing a 12-seconds breathhold.
  • Inability to perform spirometry or plethysmography maneuvers.
  • Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
  • Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773991


Contacts
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Contact: Fabio R Salerno, MD 519-685-8500 ext 56048 Fabio.Salerno@lhsc.on.ca
Contact: Tanya Tamasi, RPN 519-685-8500 ext 55975 Tanya.Tamasi@lhsc.on.ca

Locations
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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Western University, Canada
Investigators
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Principal Investigator: Christopher W McIntyre, MD PhD Lawson Health Research Institute
Publications:

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Responsible Party: Chris McIntyre, Professor of Medicine, Medical Biophysics and Paediatrics, University of Western Ontario. Director of The Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre., Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03773991    
Other Study ID Numbers: 110256
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chris McIntyre, Lawson Health Research Institute:
Dyspnea
Hemodialysis
End Stage Renal Disease
Additional relevant MeSH terms:
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Lung Diseases
Dyspnea
Kidney Diseases
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Respiration Disorders
Signs and Symptoms, Respiratory
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents