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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003179-12 | EudraCT Number | ||
| 01KG1202 | Other Grant/Funding Number | German Ministry of Education and Research |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Clinical Trial Center Wuerzburg (CTCW) | UNKNOWN |
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End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | 50mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Mass Index | as assessed by cardiac MRI | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac function parameters | cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography | 9 months |
| Office and 24h blood pressure | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Wanner, MD | Wuerzburg University Hospital | Principal Investigator |
| Fabian Hammer, MD, PhD | Wuerzburg University Hospital | Principal Investigator |
| Vera Krane, MD | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Erlangen-Nürnberg | Erlangen | 91054 | Germany | |||
| University Hospital Frankfurt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33586138 | Derived | Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2. | |
| 33544240 | Derived | Hauser T, Dornberger V, Malzahn U, Grebe SJ, Liu D, Stork S, Nauck M, Friedrich N, Dorr M, Wanner C, Krane V, Hammer F; MiREnDa Study Group; Collaborating investigators (sites). The effect of spironolactone on diastolic function in haemodialysis patients. Int J Cardiovasc Imaging. 2021 Jun;37(6):1927-1936. doi: 10.1007/s10554-021-02176-5. Epub 2021 Feb 5. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Drug |
Placebo |
|
| Clinical measures of heart failure severity | New York Heart Association (NYHA) functional class, 6 minute walk test | 9 months |
| Vascular function | Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery | 9 months |
| Biomarkers of heart failure, inflammation and fibrosis | 9 months |
| Quality of Life - Hospital Anxiety and Depression Scale (HADS) | Quality of life will be measured by analyzing HADS | 9 months |
| Cardiac death and/or hospitalization for heart failure | 9 months |
| Safety measures | Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable) | 9 months |
| Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36) | Quality of life will be measured by analyzing KDQOL-SF36 | 9 months |
| Frankfurt |
| 60590 |
| Germany |
| University Hospital Wuerzburg | Würzburg | 97080 | Germany |
| 32938484 | Derived | Grebe SJ, Malzahn U, Donhauser J, Liu D, Wanner C, Krane V, Hammer F. Quantification of left ventricular mass by echocardiography compared to cardiac magnet resonance imaging in hemodialysis patients. Cardiovasc Ultrasound. 2020 Sep 16;18(1):39. doi: 10.1186/s12947-020-00217-y. |
| 24166468 | Derived | Hammer F, Krane V, Stork S, Roser C, Hofmann K, Pollak N, Allolio B, Wanner C. Rationale and design of the Mineralocorticoid Receptor Antagonists in End-Stage Renal Disease Study (MiREnDa). Nephrol Dial Transplant. 2014 Feb;29(2):400-5. doi: 10.1093/ndt/gft409. Epub 2013 Oct 28. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |