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The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty

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ClinicalTrials.gov Identifier: NCT03663049
Recruitment Status : Unknown
Verified April 2019 by Julia Schneider, Loyola University.
Recruitment status was:  Recruiting
First Posted : September 10, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Julia Schneider, Loyola University

Study Description
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Brief Summary:
Patients who are on chronic dialysis and 70 and older are frequently on multiple medications including statins. However, the benefit of statins in dialysis patient population is uncertain. Several randomized trials showed no benefit of statins on mortality in dialysis patient population. Guidelines recommend not starting statins in patients on dialysis who are not already taking them. However, there are no guidelines on what to do in patients who are already taking statins. The investigators are doing a short pilot study to discontinue statin in our dialysis patient population and evaluating the effects on discontinuation of statins on quality of life, cognition, as physical strength.

Condition or disease Intervention/treatment Phase
ESRD Cardiovascular Diseases Drug: discontinue statin Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arms in the study. Patients will be randomized to either continue medication in the statin group or discontinue.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Trial of Statin Holiday in Patients Receiving Maintenance Dialysis
Actual Study Start Date : August 17, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: discontinue statin
Discontinue statin as prescribed for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 70 years and older,
  2. Receiving maintenance dialysis for at least 6 months,
  3. Must be on a statin medication,
  4. Receiving dialysis at the Loyola University Medical Center dialysis unit ,
  5. Can be on hemodialysis or peritoneal dialysis,

Exclusion Criteria:

  1. Age less than 70 years old
  2. Any recent hospital admission (within 2 weeks)
  3. Recent dialysis start (within 6 months)
  4. Any cancer diagnosis, with exception of innocuous skin cancers and previously treated cancers
  5. Any recent (< 1 year) solid organ transplant
  6. Active on kidney transplant wait list
  7. Recent acute coronary event (e.g. recent NSTEMI, stent, angioplasty, CABG) within 6 months
  8. Non-English speaking
  9. Diagnosis of dementia
  10. Patients who are unable to provide informed consent
Contacts and Locations
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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): NCT03663049


Contacts
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Contact: Julia M Schneider 7082169000 julia.schneider@luhs.org
Contact: Holly M Kramer 7082169000 hkramer@lumc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Loyola University M Center    708-216-9000    julia.schneider@luhs.org   
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Julia Schneider Loyola University Chicago
More Information
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Additional Information:

Publications:
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, Fellström B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Grönhagen-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.
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

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Responsible Party: Julia Schneider, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03663049    
Other Study ID Numbers: 210890
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases