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

NCT03663049 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 210890
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in quality of life

  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 Outcomes (1)

• Change in handgrip strength

  Change in handgrip strength over 12 weeks

Other Outcomes (3)

• Change in cognition

  Change in cognition over 12 weeks

• Change in frailty

  Change in frailty at 12 weeks

• Change in mobility

  Change in mobility at 12 weeks

Study Arms (2)

Usual care

NO INTERVENTION

These patients will continue as statins as usual.

Discontinue statin

EXPERIMENTAL

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

Interventions

discontinue statin DRUG

Discontinue statin as prescribed for 12 weeks

Discontinue statin

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (20)

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  PMID: 19332456 BACKGROUND

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  PMID: 23975627 BACKGROUND

• 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.

  PMID: 24552851 BACKGROUND

• 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.

  PMID: 12552501 BACKGROUND

• 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

  BACKGROUND

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  PMID: 20576825 BACKGROUND

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Related Links

• Drug Safety and Availability - FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs \[Internet\].: Center for Drug Evaluation and Research \[cited Mar 9, 2018\]

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Schneider

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia M Schneider

CONTACT

7082169000; julia.schneider@luhs.org

Holly M Kramer

CONTACT

7082169000; hkramer@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two arms in the study. Patients will be randomized to either continue medication in the statin group or discontinue.

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: August 17, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)