The Impact of Statin Holiday in Dialysis Patients Over 70 Years Old on Mental Function, Physical Function and Frailty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03663049|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|ESRD Cardiovascular Diseases||Drug: discontinue statin||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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
- 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 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 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 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 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
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
|Contact: Julia M Schneideremail@example.com|
|Contact: Holly M Kramerfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Loyola University M Center 708-216-9000 email@example.com|
|Principal Investigator:||Julia Schneider||Loyola University Chicago|