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

April 19, 2019 updated by: Julia Schneider, Loyola University

Trial of Statin Holiday in Patients Receiving Maintenance Dialysis

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: discontinue statin
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

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Julia Schneider, Loyola University Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2018

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

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)?

No

Drug and device information, study documents

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

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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