| Trial ID: | L1063 |
| Source ID: | NCT02502981
|
| Associated Drug: |
Spironolactone
|
| Title: |
Comparing the Effects of Spironolactone With Chlortalidone on LV Mass in Patients With CKD
|
| Acronym: |
SPIRO-CKD
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic|Cardio-Renal Syndrome
|
| Interventions: |
DRUG: Spironolactone|DRUG: Chlortalidone
|
| Outcome Measures: |
Primary: Change in LV mass measured by cardiac MRI, week 40 | Secondary: Change in arterial stiffness measured by carotid-femoral pulse wave velocity, up to week 40|Change in serum potassium, Potassium will be assessed at baseline, week 1,2,4,8,20 and week 40, up to week 40|Change in 24 hour ambulatory blood pressure, Patients will wear an ambulatory monitor at week 0 and 40, up to week 40|Change in left ventricular systolic function as measured by Global longitudinal strain using MR tagging, Global longitudinal strain (%) will be assessed at week 0 and 40, up to week 40|Change in renal function, Estimated GFR will calculated using the Modification of Diet in Renal Disease equation at baseline, week 1,2,4,8,20 and week 40, up to week 40
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Birmingham | Collaborators: Royal Free Hospital NHS Foundation Trust|University of Edinburgh|University of Cambridge
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
154
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2018-05
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-19
|
| Locations: |
Departments of Cardiology & Nephrology University Hospital Birmingham, Birmingham, West Midlands, B15 2TH, United Kingdom|Cambridge Clinical Trials Unit, University of Cambridge and Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom|University of Edinburgh: BHF Centre for Cardiovascular Science and Western General Hospital, Edinburgh, EH16 4TJ, United Kingdom|Royal Free Hospital, London, NW3 2QG, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02502981
|
