End-stage Renal DiseaseNCT00718848
Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease
An observational study of End-stage Renal Disease and Left Ventricular Hypertrophy, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights per week) may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood pressure control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Left Ventricular Hypertrophy
- What is being tested?
- Incentre nocturnal hemodialysis and Remaining on conventional hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who convert to in-centre nocturnal hemodialysis and their matched controls will be drawn from a population of prevalent chronic hemodialysis patients.
Who may be able to join
- adult patients currently treated with conventional hemodialysis for > 6 months
Who cannot join
- acute coronary syndrome or coronary revascularization (percutaneous coronary intervention, coronary bypass surgery) within the past 6 months
- uncontrolled hypertension (systolic blood pressure > 200 mmHg, or diastolic blood pressure > 120 mmHg)
- severe heart failure (New York Heart Association functional class IV)
- chronic atrial fibrillation
- serious co-morbidity (e.g. cancer) with a life expectancy of less than 1 year
- pregnancy
Show all 9Show fewer
- patient refusal to undergo baseline CMR
- contraindications to CMR (e.g. pacemaker, implantable cardiac defibrillator)
- inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights per week) may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3 nights per week, represents an appealing and practical alternative. As this is a novel form of therapy, there has been no definitive study examining the cardiovascular impact of INHD to date.
Objective: To determine the effects of INHD on LV mass, global and regional systolic and diastolic function, and other cardiovascular biomarkers in patients with ESRD.
Read more
Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable changes in cardiac structure and function in patients with ESRD.
Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the new gold standard for measuring LV mass, volume, global and regional myocardial function. Its accuracy and precision make it the imaging modality of choice for studying the small number of patients currently undergoing or awaiting INHD.
Study Design and Population: This is a prospective cohort study of adult ESRD patients who are currently receiving conventional in-centre hemodialysis and will be converted to INHD. Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia management) established for the INHD program, and no therapeutic intervention will be performed as part of this study. All eligible patients will undergo two serial CMR examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to INHD. We also plan to recruit a population of control patients who have elected to remain on conventional HD. These individuals will be asked to undergo the same set of investigations at baseline and 12 months thereafter.
Outcome: The primary endpoints are the temporal changes in LV mass and size, global and regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain natriuretic peptide, markers of inflammation and quality of life.
Significance: The provision of an enhanced dialysis regimen has emerged as the most promising avenue through which to modify the dismal cardiovascular outcomes in patients receiving chronic hemodialysis. INHD represents a means of administering such therapy to a broad spectrum of dialysis patients for whom home therapies would not be feasible. The proposed study will be the first to precisely define the cardiac impact of INHD using CMR. The findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD is proven to be effective, it will have a major impact on the management and outcome of many patients with ESRD in Canada.
- Being tested
- Incentre nocturnal hemodialysis, Remaining on conventional hemodialysis
- Keywords
- hemodialysis, left ventricular hypertrophy, left ventricular systolic function
- Medical subject headings
- Kidney Failure, Chronic, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentre nocturnal hemodialysisProcedure or surgery
This is a hemodialysis schedule that consists of 3 weekly hemodialysis sessions administered overnight (8 hours/session) in-hospital.
Remaining on conventional hemodialysisProcedure or surgery
These patients will remain on their current conventional hemodialysis schedule that consists of 4 hours/session, 3 sessions/week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | These are patients treated with conventional hemodialysis (4 hours/session, 3 sessions/week) who convert to incentre nocturnal hemodialysis (8 hours/session, 3 sessions/week). Receives: Procedure: Incentre nocturnal hemodialysis | |
| 2 | These are patients treated with conventional hemodialysis (4 hours/session, 3 session/week) who elect to remain on this dialysis schedule and agree to the study-related investigations at baseline and one year thereafter. Receives: Procedure: Remaining on conventional hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in left ventricular mass index
Measured: 1 year
Secondary outcomes (3)
changes in left ventricular volume and systolic function
Measured: 12 months
changes in regional left ventricular systolic and diastolic function
Measured: 12 months
changes in mineral metabolic parameters (calcium, phosphorus, parathyroid hormone)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Marc B. Goldstein, MD, Principal investigator, Unity Health TorontoAndrew T Yan, MD, Principal investigator, Unity Health TorontoRon Wald, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718848
- Sponsor's protocol ID
- 186223
- Status last verified
- Oct 2015
- First submitted
- 18 Jul 2008
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Alansari H, Wald R, Deva DP, Ong J, Chang LD, Kiaii M, Karur GR, Ng MY, Leipsic J, Yan AT. Relationships between cardiac structural and functional assessment by cardiac MRI and hemoglobin in end-stage renal disease. J Nephrol. 2021 Oct;34(5):1561-1563. doi: 10.1007/s40620-021-01123-w. Epub 2021 Jul 19. No abstract available.
PubMed 34279812Cai S, Wald R, Deva DP, Kiaii M, Ng MY, Karur GR, Bello O, Li ZJ, Leipsic J, Jimenez-Juan L, Kirpalani A, Connelly KA, Yan AT. Cardiac MRI measurements of pericardial adipose tissue volumes in patients on in-centre nocturnal hemodialysis. J Nephrol. 2020 Apr;33(2):355-363. doi: 10.1007/s40620-019-00665-4. Epub 2019 Nov 14.
PubMed 31728837Law TK, Wald R, Goldstein M, Karur GR, Ng MY, Wang AYM, Deva DP, Kirpalani A, Wald RM, Kiaii M, Leipsic J, Connelly KA, Yan AT. Left Atrial Remodeling Assessed by Cardiac MRI after Conversion from Conventional Hemodialysis to In-Centre Nocturnal Hemodialysis. J Nephrol. 2019 Apr;32(2):273-281. doi: 10.1007/s40620-018-0522-2. Epub 2018 Aug 24.
PubMed 30168083Karur GR, Wald R, Goldstein MB, Wald R, Jimenez-Juan L, Kiaii M, Leipsic J, Kirpalani A, Bello O, Barthur A, Ng MY, Deva DP, Yan AT. Association between conversion to in-center nocturnal hemodialysis and right ventricular remodeling. Nephrol Dial Transplant. 2018 Jun 1;33(6):1010-1016. doi: 10.1093/ndt/gfx232.
PubMed 28992094Sarak B, Wald R, Goldstein MB, Deva DP, Leipsic J, Kiaii M, Leung G, Barfett JJ, Perl J, Yuen DA, Connelly KA, Yan AT. Relationship between changes in blood pressure and left ventricular mass over 1 year in end-stage renal disease. J Hypertens. 2017 Aug;35(8):1709-1716. doi: 10.1097/HJH.0000000000001353.
PubMed 28319597Wald R, Goldstein MB, Perl J, Kiaii M, Yuen D, Wald RM, Harel Z, Weinstein JJ, Jakubovic B, Leong-Poi H, Kirpalani A, Leipsic J, Dacouris N, Wolf M, Yan AT. The Association Between Conversion to In-centre Nocturnal Hemodialysis and Left Ventricular Mass Regression in Patients With End-Stage Renal Disease. Can J Cardiol. 2016 Mar;32(3):369-77. doi: 10.1016/j.cjca.2015.07.004. Epub 2015 Jul 9.
PubMed 26386732
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of In-centre Nocturnal Hemodialysis on Ventricular Remodeling and Function in End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT00718848
- Acronym / sponsor ID
- 186223
- Keywords
- hemodialysis, left ventricular hypertrophy, left ventricular systolic function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Recent data indicate that home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights per week) may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and blood pressure control. Nevertheless, this dialysis modality is only feasible in a highly-selected minority of ESRD patients, who can self-manage their dialysis treatment at home. In-centre nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3 nights per week, represents an appealing and practical alternative. As this is a novel form of therapy, there has been no definitive study examining the cardiovascular impact of INHD to date.
Objective: To determine the effects of INHD on LV mass, global and regional systolic and diastolic function, and other cardiovascular biomarkers in patients with ESRD.
Hypothesis: Conversion from conventional hemodialysis to INHD is associated with favourable changes in cardiac structure and function in patients with ESRD.
Rationale for Using Cardiac MRI: Cardiac magnetic resonance imaging (CMR) has emerged as the new gold standard for measuring LV mass, volume, global and regional myocardial function. Its accuracy and precision make it the imaging modality of choice for studying the small number of patients currently undergoing or awaiting INHD.
Study Design and Population: This is a prospective cohort study of adult ESRD patients who are currently receiving conventional in-centre hemodialysis and will be converted to INHD. Patients will be managed as per standard clinical practice (e.g. blood pressure, anemia management) established for the INHD program, and no therapeutic intervention will be performed as part of this study. All eligible patients will undergo two serial CMR examinations: within 2 weeks prior to conversion and at 52 weeks following conversion to INHD. We also plan to recruit a population of control patients who have elected to remain on conventional HD. These individuals will be asked to undergo the same set of investigations at baseline and 12 months thereafter.
Outcome: The primary endpoints are the temporal changes in LV mass and size, global and regional diastolic and systolic function at 52 weeks after conversion to INHD, as measured by cardiac MRI. Secondary endpoints include changes in myocardial tissue characteristics, blood pressure, mineral metabolic parameters, anemia control, serum troponin, norepinephrine, brain natriuretic peptide, markers of inflammation and quality of life.
Significance: The provision of an enhanced dialysis regimen has emerged as the most promising avenue through which to modify the dismal cardiovascular outcomes in patients receiving chronic hemodialysis. INHD represents a means of administering such therapy to a broad spectrum of dialysis patients for whom home therapies would not be feasible. The proposed study will be the first to precisely define the cardiac impact of INHD using CMR. The findings may justify large randomized controlled trials evaluating clinical outcomes. If INHD is proven to be effective, it will have a major impact on the management and outcome of many patients with ESRD in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Incentre nocturnal hemodialysisThese are patients treated with conventional hemodialysis (4 hours/session, 3 sessions/week) who convert to incentre nocturnal hemodialysis (8 hours/session, 3 sessions/week). |
| 2 | – | Procedure: Remaining on conventional hemodialysisThese are patients treated with conventional hemodialysis (4 hours/session, 3 session/week) who elect to remain on this dialysis schedule and agree to the study-related investigations at baseline and one year thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who convert to in-centre nocturnal hemodialysis and their matched controls will be drawn from a population of prevalent chronic hemodialysis patients.
Key inclusion criteria (1 listed)
- adult patients currently treated with conventional hemodialysis for > 6 months
Key exclusion criteria (9 listed)
- acute coronary syndrome or coronary revascularization (percutaneous coronary intervention, coronary bypass surgery) within the past 6 months
- uncontrolled hypertension (systolic blood pressure > 200 mmHg, or diastolic blood pressure > 120 mmHg)
- severe heart failure (New York Heart Association functional class IV)
- chronic atrial fibrillation
- serious co-morbidity (e.g. cancer) with a life expectancy of less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentre nocturnal hemodialysisThis is a hemodialysis schedule that consists of 3 weekly hemodialysis sessions administered overnight (8 hours/session) in-hospital. | Procedure or surgery | 1 |
| Remaining on conventional hemodialysisThese patients will remain on their current conventional hemodialysis schedule that consists of 4 hours/session, 3 sessions/week. | Procedure or surgery | 2 |
Primary outcome
change in left ventricular mass index
Time frame: 1 year
3 secondary outcomes
changes in left ventricular volume and systolic function
Time frame: 12 months
changes in regional left ventricular systolic and diastolic function
Time frame: 12 months
changes in mineral metabolic parameters (calcium, phosphorus, parathyroid hormone)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Derived from this study: PubMed 34279812Alansari H, Wald R, Deva DP, Ong J, Chang LD, Kiaii M, Karur GR, Ng MY, Leipsic J, Yan AT. Relationships between cardiac structural and functional assessment by cardiac MRI and hemoglobin in end-stage renal disease. J Nephrol. 2021 Oct;34(5):1561-1563. doi: 10.1007/s40620-021-01123-w. Epub 2021 Jul 19. No abstract available.
- Derived from this study: PubMed 31728837Cai S, Wald R, Deva DP, Kiaii M, Ng MY, Karur GR, Bello O, Li ZJ, Leipsic J, Jimenez-Juan L, Kirpalani A, Connelly KA, Yan AT. Cardiac MRI measurements of pericardial adipose tissue volumes in patients on in-centre nocturnal hemodialysis. J Nephrol. 2020 Apr;33(2):355-363. doi: 10.1007/s40620-019-00665-4. Epub 2019 Nov 14.
- Derived from this study: PubMed 30168083Law TK, Wald R, Goldstein M, Karur GR, Ng MY, Wang AYM, Deva DP, Kirpalani A, Wald RM, Kiaii M, Leipsic J, Connelly KA, Yan AT. Left Atrial Remodeling Assessed by Cardiac MRI after Conversion from Conventional Hemodialysis to In-Centre Nocturnal Hemodialysis. J Nephrol. 2019 Apr;32(2):273-281. doi: 10.1007/s40620-018-0522-2. Epub 2018 Aug 24.
- Derived from this study: PubMed 28992094Karur GR, Wald R, Goldstein MB, Wald R, Jimenez-Juan L, Kiaii M, Leipsic J, Kirpalani A, Bello O, Barthur A, Ng MY, Deva DP, Yan AT. Association between conversion to in-center nocturnal hemodialysis and right ventricular remodeling. Nephrol Dial Transplant. 2018 Jun 1;33(6):1010-1016. doi: 10.1093/ndt/gfx232.
- Derived from this study: PubMed 28319597Sarak B, Wald R, Goldstein MB, Deva DP, Leipsic J, Kiaii M, Leung G, Barfett JJ, Perl J, Yuen DA, Connelly KA, Yan AT. Relationship between changes in blood pressure and left ventricular mass over 1 year in end-stage renal disease. J Hypertens. 2017 Aug;35(8):1709-1716. doi: 10.1097/HJH.0000000000001353.
- Derived from this study: PubMed 26386732Wald R, Goldstein MB, Perl J, Kiaii M, Yuen D, Wald RM, Harel Z, Weinstein JJ, Jakubovic B, Leong-Poi H, Kirpalani A, Leipsic J, Dacouris N, Wolf M, Yan AT. The Association Between Conversion to In-centre Nocturnal Hemodialysis and Left Ventricular Mass Regression in Patients With End-Stage Renal Disease. Can J Cardiol. 2016 Mar;32(3):369-77. doi: 10.1016/j.cjca.2015.07.004. Epub 2015 Jul 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc B. Goldstein, MD principal investigator
Unity Health Toronto
Andrew T Yan, MD principal investigator
Unity Health Toronto
Ron Wald, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease and Left Ventricular Hypertrophy, run by Unity Health Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in left ventricular mass index (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00718848, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.