- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663049
The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty
Trial of Statin Holiday in Patients Receiving Maintenance Dialysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dialysis patients who are 70 years and older suffer from cognitive dysfunction, physical impairment, and frailty. Polypharmacy in this subgroup of patients is prevalent and can lead to drug toxicities and increased side effects which can contribute to adverse outcomes such as worsening cognitive decline and increased frailty. One frequent component of polypharmacy in dialysis patient population is the use of statins. The use of statins, however, has not been proven to be beneficial in this patient population. While statin medications have been shown to reduce atherosclerotic cardiovascular disease in adults without dialysis dependent chronic kidney disease (CKD), the benefit of statin use in chronic dialysis patients has not been proven. A Cochrane meta-analysis published in 2013 included 25 trials of statin medications in patients receiving maintenance dialysis (total of 8289 patients) and found no benefit of statin medications for preventing atherosclerotic cardiovascular disease events or mortality. The meta-analysis did note that evidence for side effects for statins was incomplete and potential harms from statin medications remain uncertain in this population. Furthermore, statins have recently come under scrutiny by the FDA with regards to their safety due to associations with memory loss and weakness.
Previous clinical trials of statins only assessed the known adverse effects of statins such as abnormal liver function tests and acute kidney injury, adverse effects that occur rarely (< 1%). Trials did not assess other side effects such as cognitive decline or muscle weakness that may be more common in older patients with kidney failure. The aim of this pilot study is to examine the potential side effects of statin medication use in older patients receiving dialysis by conducting a randomized pilot trial of a statin holiday (3 months of discontinuation) vs. no holiday and measuring changes in cognitive function, muscle strength, quality of life and frailty. The investigators hypothesize that measures of cognitive function, grip strength, quality of life and overall frailty will improve after 6 weeks of discontinuation of statins. After obtaining informed consent, patients will complete assessments of quality of life (SF-20), cognition, muscle strength and frailty at baseline and again at 6 and 12 weeks after statin holiday (intervention group) vs. no statin holiday (control group). All patients will resume statin medications after the 3 month trial. The overall goal is to determine whether changes in cognition, strength, frailty or quality of life can be measured using standard instruments. If changes can be detected, pilot data from this study will be used to design a larger trial.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Julia M Schneider
- Phone Number: 7082169000
- Email: julia.schneider@luhs.org
Study Contact Backup
- Name: Holly M Kramer
- Phone Number: 7082169000
- Email: hkramer@lumc.edu
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Loyola University M Center
- Phone Number: 708-216-9000
- Email: julia.schneider@luhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 70 years and older,
- Receiving maintenance dialysis for at least 6 months,
- Must be on a statin medication,
- Receiving dialysis at the Loyola University Medical Center dialysis unit ,
- Can be on hemodialysis or peritoneal dialysis,
Exclusion Criteria:
- Age less than 70 years old
- Any recent hospital admission (within 2 weeks)
- Recent dialysis start (within 6 months)
- Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
- Any recent (< 1 year) solid organ transplant
- Active on kidney transplant wait list
- Recent acute coronary event (e.g. recent NSTEMI, stent, angioplasty, CABG) within 6 months
- Non-English speaking
- Diagnosis of dementia
- Patients who are unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
These patients will continue as statins as usual.
|
|
Experimental: Discontinue statin
Patients randomized to this group will stop using the statins they are currently prescribed and will not use their statin medication for 12 weeks.
|
Discontinue statin as prescribed for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: Change in quality of life over 12 weeks
|
Change in quality of life will be measured by the Short Form Survey 20 (SF-20).
The survey assesses quality of life via 20 questions across 6 domains: physical functioning (6 questions), role functioning (2 questions), social functioning (1 question), mental health (5 questions), health perceptions (5 questions), and pain (1 question).
Scores across each of these domains are reported on a 0% to 100% scale, with 0% representing the worst possible score in that domain and 100% the best possible score.
|
Change in quality of life over 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in handgrip strength
Time Frame: Change in handgrip strength over 12 weeks
|
Handgrip strength will be measured at baseline and again at 6 and 12 weeks
|
Change in handgrip strength over 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognition
Time Frame: Change in cognition over 12 weeks
|
Cognition will be measured with trail making test at baseline and again at 6 and 12 weeks
|
Change in cognition over 12 weeks
|
Change in frailty
Time Frame: Change in frailty at 12 weeks
|
Frailty will be measured with the Fatigue, Resistance, Aeorbic, Illnesses, and Loss of weight (FRAIL) questionnaire at baseline and again at 6 and 12 weeks.
The questionnaire rates each of the five items as 0 for no and 1 for yes, with a total score of 5 possible.
Scoring scale: 1-2= pre-frail; 3 or greater=frailty
|
Change in frailty at 12 weeks
|
Change in mobility
Time Frame: Change in mobility at 12 weeks
|
Fall risk will be measured with the Get up and go test at baseline and again at 6 and 12 weeks.
Time interpretation scale: 10 seconds or less=normal; 20 seconds or less= good mobility; 20 seconds or more = mobility problems, need for a mobility aid
|
Change in mobility at 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Schneider, Loyola University Chicago
Publications and helpful links
General Publications
- Isoyama N, Qureshi AR, Avesani CM, Lindholm B, Barany P, Heimburger O, Cederholm T, Stenvinkel P, Carrero JJ. Comparative associations of muscle mass and muscle strength with mortality in dialysis patients. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1720-8. doi: 10.2215/CJN.10261013. Epub 2014 Jul 29.
- Clark DA, Khan U, Kiberd BA, Turner CC, Dixon A, Landry D, Moffatt HC, Moorhouse PA, Tennankore KK. Frailty in end-stage renal disease: comparing patient, caregiver, and clinician perspectives. BMC Nephrol. 2017 May 2;18(1):148. doi: 10.1186/s12882-017-0558-x.
- McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. Am J Kidney Dis. 2017 Nov;70(5):611-618. doi: 10.1053/j.ajkd.2017.02.374. Epub 2017 Apr 14.
- St Peter WL. Management of Polypharmacy in Dialysis Patients. Semin Dial. 2015 Jul-Aug;28(4):427-32. doi: 10.1111/sdi.12377. Epub 2015 Apr 9.
- Fellstrom BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Gronhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Suleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wuthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30. Erratum In: N Engl J Med. 2010 Apr 15;362(15):1450.
- Holdaas H, Holme I, Schmieder RE, Jardine AG, Zannad F, Norby GE, Fellstrom BC; AURORA study group. Rosuvastatin in diabetic hemodialysis patients. J Am Soc Nephrol. 2011 Jul;22(7):1335-41. doi: 10.1681/ASN.2010090987. Epub 2011 May 12.
- Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.
- Olyaei A, Steffl JL, MacLaughlan J, Trabolsi M, Quadri SP, Abbasi I, Lerma E. HMG-CoA reductase inhibitors in chronic kidney disease. Am J Cardiovasc Drugs. 2013 Dec;13(6):385-98. doi: 10.1007/s40256-013-0041-4.
- Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.
- Manley HJ, McClaran ML, Overbay DK, Wright MA, Reid GM, Bender WL, Neufeld TK, Hebbar S, Muther RS. Factors associated with medication-related problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003 Feb;41(2):386-93. doi: 10.1053/ajkd.2003.50048.
- Talar Markossian, Holly Kramer, Nicholas Burge, et a. Utilization of statins in U.S. Veterans with dialysis-dependent chronic kidney disease. Health Sciences Research. 2018 Under review
- Kurella Tamura M, Larive B, Unruh ML, Stokes JB, Nissenson A, Mehta RL, Chertow GM; Frequent Hemodialysis Network Trial Group. Prevalence and correlates of cognitive impairment in hemodialysis patients: the Frequent Hemodialysis Network trials. Clin J Am Soc Nephrol. 2010 Aug;5(8):1429-38. doi: 10.2215/CJN.01090210. Epub 2010 Jun 24.
- Johansen KL, Chertow GM, Jin C, Kutner NG. Significance of frailty among dialysis patients. J Am Soc Nephrol. 2007 Nov;18(11):2960-7. doi: 10.1681/ASN.2007020221. Epub 2007 Oct 17. No abstract available.
- Herzog CA, Asinger RW, Berger AK, Charytan DM, Diez J, Hart RG, Eckardt KU, Kasiske BL, McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2011 Sep;80(6):572-86. doi: 10.1038/ki.2011.223. Epub 2011 Jul 13.
- Dong J, Pi HC, Xiong ZY, Liao JL, Hao L, Liu GL, Ren YP, Wang Q, Duan LP, Zheng ZX. Depression and Cognitive Impairment in Peritoneal Dialysis: A Multicenter Cross-sectional Study. Am J Kidney Dis. 2016 Jan;67(1):111-8. doi: 10.1053/j.ajkd.2015.06.025. Epub 2015 Aug 6.
- Fazekas G, Fazekas F, Schmidt R, Kapeller P, Offenbacher H, Krejs GJ. Brain MRI findings and cognitive impairment in patients undergoing chronic hemodialysis treatment. J Neurol Sci. 1995 Dec;134(1-2):83-8. doi: 10.1016/0022-510x(95)00226-7.
- Sehgal AR, Grey SF, DeOreo PB, Whitehouse PJ. Prevalence, recognition, and implications of mental impairment among hemodialysis patients. Am J Kidney Dis. 1997 Jul;30(1):41-9. doi: 10.1016/s0272-6386(97)90563-1.
- Lopes AA, Lantz B, Morgenstern H, Wang M, Bieber BA, Gillespie BW, Li Y, Painter P, Jacobson SH, Rayner HC, Mapes DL, Vanholder RC, Hasegawa T, Robinson BM, Pisoni RL. Associations of self-reported physical activity types and levels with quality of life, depression symptoms, and mortality in hemodialysis patients: the DOPPS. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1702-12. doi: 10.2215/CJN.12371213. Epub 2014 Oct 2.
- Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.
- Painter P, Marcus RL. Assessing physical function and physical activity in patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):861-72. doi: 10.2215/CJN.06590712. Epub 2012 Dec 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210890
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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