Recruiting

Statin Holiday

Sponsor:

Loyola University

Code:

NCT03663049

Conditions

ESRD

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

discontinue statin

Study Details

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

Study ID

NCT03663049

Start date

Aug 17, 2018

Status verified date

Apr, 2019

Completion date

May, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

discontinue statin

Discontinue statin as prescribed for 12 weeks

Primary outcome measure

  • Change in quality of life [ Time Frame: Change in quality of life over 12 weeks ]

Central Contacts and Locations

Central contacts

Julia M Schneider

7082169000julia.schneider@luhs.org

Holly M Kramer

7082169000hkramer@lumc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Loyola University M Center

708-216-9000julia.schneider@luhs.org

More Information

Sponsor

Loyola University

Last update posted

Apr 23, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2019-04-23.