- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773991
Dyspnea Assessment in Hemodialysis Patients
Multimodal Assessment of Dyspnea, Cardiopulmonary Structure and Function in Chronic Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
- 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
Detailed Description
Rationale:
The available evidence suggest that End-Stage Renal Disease (ESRD) and hemodialysis (HD) have harmful effects on the lungs; the investigators hypothesize that these recurring pulmonary insults, in an analogous way as recurring myocardial ischemic injury for the heart, cause long term impairment in the pulmonary parenchyma, airways and circulation. In addition, observational studies have reported that dyspnea is a common symptom among ESRD patients on chronic HD treatment; however, no study up to now has directly addressed the issue, so that the relationship between dyspnea and pulmonary involvement in the HD population remains poorly understood.
The aim of this study is to explore the pathophysiological basis of dyspnea in patients with end stage renal disease on chronic HD, by using state-of-the-art imaging and functional study techniques.
Study Design:
This is an exploratory study involving a single center recruiting patients from the prevalent dialysis population of London, Ontario. 20 patients on maintenance hemodialysis will be recruited. The patients will undergo imaging, functional studies and blood sampling at the Robarts Research Institute on a non-dialysis day, during the short interval in the dialysis schedule, at baseline and after one year.
Study Procedures:
Blood Collection: blood will be collected from a venous access for standard-of-care tests, uremia and inflammation biomarkers.
Dyspnea Assessment: dyspnea will be assessed with the following self-administered questionnaires: Modified Medical Research Council Breathlessness Scale, the University of California, San Diego Shortness of Breath Questionnaire Pulmonary Function Tests: spirometry and plethysmography pre and post salbutamol administration, carbon monoxide diffusion (DLCO) and the fractional exhaled nitric oxide (FeNO) will be evaluated.
Six Minute Walk Test: the subjects able to do so will perform a six minute walk test, their dyspnea and overall fatigue at baseline and at the end of the exercise will be evaluated using the Borg Scale.
Lung MRI: a proton MRI with ultrashort echo time (UTE) acquisition sequences for the study of lung parenchyma and lung water will be employed. Images will be acquired twice, both pre and post a bronchodilator (salbutamol) challenge.
Sodium MRI: a proton T1 weighted fast-low-angle-shot (FLASH)- sequence will be acquired to delineate the anatomy of the lower leg. Then, a sodium MRI study of the subjects' legs (~5 cm below the knee) will be obtained with the custom-made sodium coil at 3.0 Tesla.
Water content will also be quantified using proton-MRI with fat-suppressed inversion recovery sequence with proton density contrast.
Chest CT: a high-resolution chest CT scan will be performed using a 64-slice CT scanner. A low radiation dose protocol will be employed. A qualitative and quantitative evaluation of pulmonary airways, blood vessels and parenchyma will be performed.
2D Transthoracic Echocardiography: images will be taken in the left lateral decubitus. Images and loops from standard parasternal long axis and short axis, subcostal, apical 4, 2 and 3- chamber views will be recorded and analyzed for: global longitudinal strain, left ventricular ejection fraction, left ventricular mass, left atrial volume, right ventricular diameter, right atrial volume, right ventricular wall thickness, tricuspid annular plane systolic excursion, pulmonary artery systolic pressure, E/A ratio, E/E' ratio at the basal interventricular septum, aortic, mitral, tricuspid and pulmonary valve qualitative and quantitative function.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada
- London Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Maintenance Hemodialysis Patients
Patients on chronic hemodialysis therapy due to end-stage renal disease.
|
Proton Lung Magnetic Resonance Imaging
Sodium Soft Tissue Magnetic Resonance Imaging
High-resolution Quantitative Chest CT
Transthoracic 2D Speckle-Tracking Echocardiography
Fractional Exhaled Nitric Oxide testing
Spirometry and Plethysmography
Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins
Six-Minute Walk Test
Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline
|
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). |
Baseline
|
Baseline pulmonary artery diameter.
Time Frame: Baseline
|
Baseline pulmonary artery diameter (in millimeters) by chest Computed Tomography.
|
Baseline
|
Baseline lung total blood vessel volume.
Time Frame: Baseline
|
Baseline lung total blood vessel volume in ml by chest Computed Tomography.
|
Baseline
|
Baseline lung total airway count.
Time Frame: Baseline
|
Baseline lung total airway count by chest Computed Tomography.
|
Baseline
|
Baseline lung low attenuation area.
Time Frame: Baseline
|
Baseline lung low attenuation area by chest Computed Tomography.
|
Baseline
|
Baseline lung water content.
Time Frame: Baseline
|
Baseline lung water content in arbitrary units measured by proton Magnetic Resonance Imaging.
|
Baseline
|
Baseline soft tissue sodium content.
Time Frame: Baseline
|
Baseline soft tissue sodium content in mmol/L measured by sodium Magnetic Resonance Imaging.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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). |
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
Baseline pulmonary artery systolic pressure.
Time Frame: Baseline
|
Baseline pulmonary artery systolic pressure (in mmHg), measured by transthoracic doppler echocardiography.
|
Baseline
|
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.
|
Baseline and one year
|
Baseline fractional exhaled nitric oxide.
Time Frame: Baseline
|
Baseline fractional exhaled nitric oxide measured (in parts per billion).
|
Baseline
|
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.
|
Baseline and one year
|
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.
|
Baseline
|
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.
|
Baseline and one year
|
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.
|
Baseline
|
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
|
Baseline and one year
|
Baseline six minute walk distance.
Time Frame: Baseline
|
Baseline six minute walk distance (in meters) measured by six minute walk test.
|
Baseline
|
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.
|
Baseline and one year
|
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.
|
Baseline and one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher W McIntyre, MD PhD, Lawson Health Research Institute
Publications and helpful links
General Publications
- Murtagh FE, Addington-Hall JM, Edmonds PM, Donohoe P, Carey I, Jenkins K, Higginson IJ. Symptoms in advanced renal disease: a cross-sectional survey of symptom prevalence in stage 5 chronic kidney disease managed without dialysis. J Palliat Med. 2007 Dec;10(6):1266-76. doi: 10.1089/jpm.2007.0017.
- Fairshter RD, Vaziri ND, Mirahmadi MK. Lung pathology in chronic hemodialysis patients. Int J Artif Organs. 1982 Mar;5(2):97-100.
- Zoccali C, Torino C, Tripepi R, Tripepi G, D'Arrigo G, Postorino M, Gargani L, Sicari R, Picano E, Mallamaci F; Lung US in CKD Working Group. Pulmonary congestion predicts cardiac events and mortality in ESRD. J Am Soc Nephrol. 2013 Mar;24(4):639-46. doi: 10.1681/ASN.2012100990. Epub 2013 Feb 28.
- Nascimento MM, Qureshi AR, Stenvinkel P, Pecoits-Filho R, Heimburger O, Cederholm T, Lindholm B, Barany P. Malnutrition and inflammation are associated with impaired pulmonary function in patients with chronic kidney disease. Nephrol Dial Transplant. 2004 Jul;19(7):1823-8. doi: 10.1093/ndt/gfh190. Epub 2004 May 18.
- Wallin CJ, Jacobson SH, Leksell LG. Subclinical pulmonary oedema and intermittent haemodialysis. Nephrol Dial Transplant. 1996 Nov;11(11):2269-75. doi: 10.1093/oxfordjournals.ndt.a027147.
- Bolignano D, Rastelli S, Agarwal R, Fliser D, Massy Z, Ortiz A, Wiecek A, Martinez-Castelao A, Covic A, Goldsmith D, Suleymanlar G, Lindholm B, Parati G, Sicari R, Gargani L, Mallamaci F, London G, Zoccali C. Pulmonary hypertension in CKD. Am J Kidney Dis. 2013 Apr;61(4):612-22. doi: 10.1053/j.ajkd.2012.07.029. Epub 2012 Nov 17. Erratum In: Am J Kidney Dis. 2015 Mar;65(3):524.
- Barak M, Nakhoul F, Katz Y. Pathophysiology and clinical implications of microbubbles during hemodialysis. Semin Dial. 2008 May-Jun;21(3):232-8. doi: 10.1111/j.1525-139X.2008.00424.x. Epub 2008 Mar 18.
- Plesner LL, Warming PE, Nielsen TL, Dalsgaard M, Schou M, Host U, Rydahl C, Brandi L, Kober L, Vestbo J, Iversen K. Chronic obstructive pulmonary disease in patients with end-stage kidney disease on hemodialysis. Hemodial Int. 2016 Jan;20(1):68-77. doi: 10.1111/hdi.12342. Epub 2015 Aug 5.
- Pabst S, Hammerstingl C, Hundt F, Gerhardt T, Grohe C, Nickenig G, Woitas R, Skowasch D. Pulmonary hypertension in patients with chronic kidney disease on dialysis and without dialysis: results of the PEPPER-study. PLoS One. 2012;7(4):e35310. doi: 10.1371/journal.pone.0035310. Epub 2012 Apr 18.
- Herrero JA, Alvarez-Sala JL, Coronel F, Moratilla C, Gamez C, Sanchez-Alarcos JM, Barrientos A. Pulmonary diffusing capacity in chronic dialysis patients. Respir Med. 2002 Jul;96(7):487-92. doi: 10.1053/rmed.2002.1346.
- Kovacevic P, Stanetic M, Rajkovaca Z, Meyer FJ, Vukoja M. Changes in spirometry over time in uremic patients receiving long-term hemodialysis therapy. Pneumologia. 2011 Jan-Mar;60(1):36-9.
- McIntyre CW, Odudu A. Hemodialysis-associated cardiomyopathy: a newly defined disease entity. Semin Dial. 2014 Mar;27(2):87-97. doi: 10.1111/sdi.12197.
- Belem LC, Zanetti G, Souza AS Jr, Hochhegger B, Guimaraes MD, Nobre LF, Rodrigues RS, Marchiori E. Metastatic pulmonary calcification: state-of-the-art review focused on imaging findings. Respir Med. 2014 May;108(5):668-76. doi: 10.1016/j.rmed.2014.01.012. Epub 2014 Feb 6.
- Incalzi RA, Corsonello A, Pedone C, Battaglia S, Paglino G, Bellia V; Extrapulmonary Consequences of COPD in the Elderly Study Investigators. Chronic renal failure: a neglected comorbidity of COPD. Chest. 2010 Apr;137(4):831-7. doi: 10.1378/chest.09-1710. Epub 2009 Nov 10.
- Romoff MS, Keusch G, Campese VM, Wang MS, Friedler RM, Weidmann P, Massry SG. Effect of sodium intake on plasma catecholamines in normal subjects. J Clin Endocrinol Metab. 1979 Jan;48(1):26-31. doi: 10.1210/jcem-48-1-26. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Signs and Symptoms, Respiratory
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Heart Diseases
- Kidney Diseases
- Lung Diseases
- Kidney Failure, Chronic
- Dyspnea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 110256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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