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出境医 / 临床实验 / FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life (FREDI-CAL)

FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life (FREDI-CAL)

Study Description
Brief Summary:

Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.

In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.

Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.


Condition or disease
Kidney Failure

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020
Arms and Interventions
Group/Cohort
In-Centre Haemodiafiltration (ICHDF) Group
Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.
Home HaemoDialysis (HHD) Group
Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.
Outcome Measures
Primary Outcome Measures :
  1. Pre- and post-dialysis levels of BNP [ Time Frame: 12 months ]
    Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.

  2. Pre- and post-dialysis levels of NTpro-BNP [ Time Frame: 12 months ]
    N-terminal pro-brain natriuretic peptide (NTpro-BNP) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.

  3. Pre- and post-dialysis levels of TNT [ Time Frame: 12 months ]
    Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples

  4. Pre- and post-dialysis levels of Tnl [ Time Frame: 12 months ]
    Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.

  5. Left-ventricular mass [ Time Frame: 12 months ]
    Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study

  6. Ejection fraction [ Time Frame: 12 months ]
    Visual Ejection fraction, Biplane Ejection fraction

  7. Left ventricular global strain [ Time Frame: 12 months ]
    Average GLS

  8. Right atrial volume [ Time Frame: 12 months ]
    Dertermine using echocardiogram

  9. Integrated Back Scatter [ Time Frame: 12 months ]
    Dertermine using echocardiogram


Secondary Outcome Measures :
  1. Peripheral skeletal muscle oxygenation using near-infrared spectroscopy [ Time Frame: 12 months ]
    Pulmonary gas exchange analyser generated data file

  2. Maximal cardiopulmonary exercise testing (CPET) [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function

  3. Breath-by-breath changes in pulmonary gas exchange and ventilation [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function

  4. Objective assessment of habitual physical activity using a triaxial [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up

  5. Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up

  6. Blood pressure measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for blood pressure

  7. Cardiac index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac index

  8. Stroke volume measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for stroke volume

  9. Cardiac output measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac output

  10. Total peripheral resistance measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance

  11. Cardiac power index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index

  12. Concentration of pre and post dialysis Beta-2-microglobulin [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy

  13. Cncentration of pre-dialysis FGF-23 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy

  14. Cncentration of pre-dialysis High-sensitivity CRP [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy

  15. Cncentration of pre-dialysis Interleukin-6 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy

  16. Cncentration of pre-dialysis Interleukin-10 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy

  17. Urine creatinine level [ Time Frame: 12 months ]
    Residual renal function

  18. Urine urea level [ Time Frame: 12 months ]
    Residual renal function

  19. RAPA score [ Time Frame: 12 months ]
    Derivered from RAPA questionnaire

  20. KDQoL-36 score [ Time Frame: 12 months ]
    Derivered from KDQoL-36 questionnaire

  21. FACIT-F score [ Time Frame: 12 months ]
    Derivered from FACIT-F questionnaire

  22. Recovery time [ Time Frame: 12 months ]
    Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session

  23. Lean tissue mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring

  24. fat mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring

  25. Extra/intracellular water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring

  26. Total body water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring

  27. Saliva flow rate [ Time Frame: 12 months ]
    Part of hydration status determiantion

  28. Change in number of antihypertensive agents [ Time Frame: Over 12 months period ]
    Number of antihypertensive agents

  29. Change in erythropoietin dosage [ Time Frame: Over 12 months period ]
    Erythropoietin dosage

  30. Number of in-patient days with cause [ Time Frame: Over 12 months period ]
    Date of hospital admission and date of hospital discharge

  31. Major adverse cardiovascular events (MACE) [ Time Frame: Over 12 months period ]
    Number of events considered a Major Adverse Cardiovascular Event

  32. All-cause and cardiovascular mortality [ Time Frame: Over 12 months period ]
    Number of withdrawal Information: Death of patient


Eligibility Criteria
Layout table for eligibility information
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 start aims to recruit at the Wessex Kidney Centre, a regional renal and transplant centre based at Queen Alexandra Hospital, Portsmouth, UK (part of Portsmouth Hospitals NHS Trust). The patients involved in the study would have chosen their modality of dialysis in accordance with standard clinical practice and will not change any aspect of their treatment to meet the requirements of this study.
Criteria

Inclusion Criteria:

  • Receiving HHD or ICHDF for more than 3 months and less than 36 months.
  • Haemoglobin equal to or greater than100 g/L at enrolment.
  • Willing and physically able to undertake the study assessments/tests
  • Willing to provide blood for storage and future analysis
  • Able to give informed consent

Exclusion Criteria:

  • Living donor transplant or change to peritoneal dialysis planned
  • Physical assessments contraindicated for the following clinical reasons

    • Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation).
    • Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness)
    • Symptomatic aortic stenosis
    • New York Heart Association grade IV Heart failure
    • Severe chronic obstructive pulmonary disease
    • Acute pulmonary embolus or pulmonary infarction in the last 3 months
    • Current acute myocarditis or pericarditis
    • Suspected or known dissecting aneurysm
    • Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
  • Pregnancy
  • Life expectancy of less than twelve months
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Alice Mortlock, PhD    +44 2392 286000 ext 4042    alice.mortlock@porthosp.nhs.uk   
Contact: Yishan Zheng, PhD    +44 2392 286000 ext 5210    Yishan.Zheng@porthosp.nhs.uk   
Principal Investigator: Robert Lewis         
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
NxStage Medical
University of Portsmouth
Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 24, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date March 19, 2019
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2019)
  • Pre- and post-dialysis levels of BNP [ Time Frame: 12 months ]
    Brain Natriuretic Peptide (BNP) is one of the biomarkers of myocardial damage, it's level will be measued in EDTA anticoagulated participants' blood samples.
  • Pre- and post-dialysis levels of NTpro-BNP [ Time Frame: 12 months ]
    N-terminal pro-brain natriuretic peptide (NTpro-BNP) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
  • Pre- and post-dialysis levels of TNT [ Time Frame: 12 months ]
    Troponin-T (TNT) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples
  • Pre- and post-dialysis levels of Tnl [ Time Frame: 12 months ]
    Troponin-L (Tnl) is one of the biomarkers of myocardial damage, it's level will be measued in participants' serum samples.
  • Left-ventricular mass [ Time Frame: 12 months ]
    Left-ventricular mass is a well-established measure that can independently predict adverse cardiovascular events and will be determined using echocardiogram in this study
  • Ejection fraction [ Time Frame: 12 months ]
    Visual Ejection fraction, Biplane Ejection fraction
  • Left ventricular global strain [ Time Frame: 12 months ]
    Average GLS
  • Right atrial volume [ Time Frame: 12 months ]
    Dertermine using echocardiogram
  • Integrated Back Scatter [ Time Frame: 12 months ]
    Dertermine using echocardiogram
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 25, 2019)
  • Peripheral skeletal muscle oxygenation using near-infrared spectroscopy [ Time Frame: 12 months ]
    Pulmonary gas exchange analyser generated data file
  • Maximal cardiopulmonary exercise testing (CPET) [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
  • Breath-by-breath changes in pulmonary gas exchange and ventilation [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
  • Objective assessment of habitual physical activity using a triaxial [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
  • Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
  • Blood pressure measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for blood pressure
  • Cardiac index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac index
  • Stroke volume measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for stroke volume
  • Cardiac output measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac output
  • Total peripheral resistance measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance
  • Cardiac power index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index
  • Concentration of pre and post dialysis Beta-2-microglobulin [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Cncentration of pre-dialysis FGF-23 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Cncentration of pre-dialysis High-sensitivity CRP [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Cncentration of pre-dialysis Interleukin-6 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Cncentration of pre-dialysis Interleukin-10 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Urine creatinine level [ Time Frame: 12 months ]
    Residual renal function
  • Urine urea level [ Time Frame: 12 months ]
    Residual renal function
  • RAPA score [ Time Frame: 12 months ]
    Derivered from RAPA questionnaire
  • KDQoL-36 score [ Time Frame: 12 months ]
    Derivered from KDQoL-36 questionnaire
  • FACIT-F score [ Time Frame: 12 months ]
    Derivered from FACIT-F questionnaire
  • Recovery time [ Time Frame: 12 months ]
    Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session
  • Lean tissue mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • fat mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Extra/intracellular water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Total body water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Saliva flow rate [ Time Frame: 12 months ]
    Part of hydration status determiantion
  • Change in number of antihypertensive agents [ Time Frame: Over 12 months period ]
    Number of antihypertensive agents
  • Change in erythropoietin dosage [ Time Frame: Over 12 months period ]
    Erythropoietin dosage
  • Number of in-patient days with cause [ Time Frame: Over 12 months period ]
    Date of hospital admission and date of hospital discharge
  • Major adverse cardiovascular events (MACE) [ Time Frame: Over 12 months period ]
    Number of events considered a Major Adverse Cardiovascular Event
  • All-cause and cardiovascular mortality [ Time Frame: Over 12 months period ]
    Number of withdrawal Information: Death of patient
Original Secondary Outcome Measures
 (submitted: April 18, 2019)
  • Peripheral skeletal muscle oxygenation using near-infrared spectroscopy [ Time Frame: 12 months ]
    Pulmonary gas exchange analyser generated data file
  • Maximal cardiopulmonary exercise testing (CPET) [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
  • Breath-by-breath changes in pulmonary gas exchange and ventilation [ Time Frame: 12 months ]
    Markers of physical fitness during a cycling exercise test, with concurrent measures of exercising physiological function
  • Objective assessment of habitual physical activity using a triaxial [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
  • Objective assessment of habitual physical activity using a triaxial accelerometer with a validated sleep diary [ Time Frame: 12 months ]
    Triaxial accelerometer generated data file consist of time went to sleep and time of waking up
  • Blood pressure measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for blood pressure
  • Cardiac index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac index
  • Stroke volume measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for stroke volume
  • Cardiac output measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac output
  • Total peripheral resistance measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for total peripheral resistance
  • Cardiac power index measued using NICOM sensor [ Time Frame: 12 months ]
    Non-invasive haemodynamic measurements using NICOM sensor for cardiac power index
  • pre and post dialysis Beta-2-microglobulin [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • pre-dialysis FGF-23 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • pre-dialysis High-sensitivity CRP [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • pre-dialysis Interleukin-6 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • pre-dialysis Interleukin-10 [ Time Frame: 12 months ]
    Markers of inflammation and dialysis adequacy
  • Urine creatinine level [ Time Frame: 12 months ]
    Residual renal function
  • Urine urea level [ Time Frame: 12 months ]
    Residual renal function
  • RAPA score [ Time Frame: 12 months ]
    Derivered from RAPA questionnaire
  • KDQoL-36 score [ Time Frame: 12 months ]
    Derivered from KDQoL-36 questionnaire
  • FACIT-F score [ Time Frame: 12 months ]
    Derivered from FACIT-F questionnaire
  • Recovery time [ Time Frame: 12 months ]
    Patient reported recovery time after dialysis sessions and length of sleep after last dialysis session
  • Lean tissue mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • fat mass [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Extra/intracellular water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Total body water [ Time Frame: 12 months ]
    Hydration status through body composition monitoring
  • Saliva flow rate [ Time Frame: 12 months ]
    Part of hydration status determiantion
  • Change in number of antihypertensive agents [ Time Frame: Over 12 months period ]
    Number of antihypertensive agents
  • Change in erythropoietin dosage [ Time Frame: Over 12 months period ]
    Erythropoietin dosage
  • Number of in-patient days with cause [ Time Frame: Over 12 months period ]
    Date of hospital admission and date of hospital discharge
  • Major adverse cardiovascular events (MACE) [ Time Frame: Over 12 months period ]
    Number of events considered a Major Adverse Cardiovascular Event
  • All-cause and cardiovascular mortality [ Time Frame: Over 12 months period ]
    Number of withdrawal Information: Death of patient
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life
Official Title FREquent DIalysis and Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity and Quality of Life: an Observational Pilot Study
Brief Summary

Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term.

In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis.

Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The start aims to recruit at the Wessex Kidney Centre, a regional renal and transplant centre based at Queen Alexandra Hospital, Portsmouth, UK (part of Portsmouth Hospitals NHS Trust). The patients involved in the study would have chosen their modality of dialysis in accordance with standard clinical practice and will not change any aspect of their treatment to meet the requirements of this study.
Condition Kidney Failure
Intervention Not Provided
Study Groups/Cohorts
  • In-Centre Haemodiafiltration (ICHDF) Group
    Participants undergoing ICHDF treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.
  • Home HaemoDialysis (HHD) Group
    Participants undergoing HHD treatment will be recruited into this group, their treatment will follow the standard care pathway in this observational study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 18, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Receiving HHD or ICHDF for more than 3 months and less than 36 months.
  • Haemoglobin equal to or greater than100 g/L at enrolment.
  • Willing and physically able to undertake the study assessments/tests
  • Willing to provide blood for storage and future analysis
  • Able to give informed consent

Exclusion Criteria:

  • Living donor transplant or change to peritoneal dialysis planned
  • Physical assessments contraindicated for the following clinical reasons

    • Acute Coronary Syndrome (ACS) within the last 3 months (chest pain, ECG changes or typical biomarker elevation).
    • Any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness)
    • Symptomatic aortic stenosis
    • New York Heart Association grade IV Heart failure
    • Severe chronic obstructive pulmonary disease
    • Acute pulmonary embolus or pulmonary infarction in the last 3 months
    • Current acute myocarditis or pericarditis
    • Suspected or known dissecting aneurysm
    • Acute systemic infection, accompanied by fever, body aches or swollen lymph glands
  • Pregnancy
  • Life expectancy of less than twelve months
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03925454
Other Study ID Numbers PHT/2017/122
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: All data will be stored anonymously once entered onto the case report form and data management database. The database will be utilised to safely and securely handle all study data and to minimise any potential risks associated with data collection. Any identifiable data, such as participant medical notes, will be kept confidential in accordance with the Caldicott Principles.
Responsible Party Portsmouth Hospitals NHS Trust
Study Sponsor Portsmouth Hospitals NHS Trust
Collaborators
  • NxStage Medical
  • University of Portsmouth
Investigators Not Provided
PRS Account Portsmouth Hospitals NHS Trust
Verification Date April 2019