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Mineralocorticoid Receptor Antagonists in End Stage Renal Disease (MiREnDa)

Primary Purpose

End Stage Renal Disease / Hemodialysis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease / Hemodialysis focused on measuring End stage renal disease, Hemodialysis, Spironolactone, Left ventricular hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Hemodialysis treatment for at least 3 months
  • At least 3 dialysis sessions per week
  • Written informed consent

Exclusion Criteria:

  • Contraindications for cardiac magnet resonance imaging (CMR)
  • Mineralocorticoid receptor antagonist treatment within the last 6 months
  • Estimated life expectancy < 12 months as judged by the nephrologist
  • History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment.
  • High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
  • Hypotension (systolic blood pressure < 100 mmHg)
  • Planned kidney transplantation (living donor) within the prospected study duration
  • Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
  • Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
  • Allergy/hypersensitivity to spironolactone
  • Non-compliance suspected or demonstrated

Sites / Locations

  • University Hospital Erlangen-Nürnberg
  • University Hospital Frankfurt
  • University Hospital Wuerzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Spironolactone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Left Ventricular Mass Index
as assessed by cardiac MRI

Secondary Outcome Measures

Cardiac function parameters
cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography
Office and 24h blood pressure
Clinical measures of heart failure severity
New York Heart Association (NYHA) functional class, 6 minute walk test
Vascular function
Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery
Biomarkers of heart failure, inflammation and fibrosis
Quality of Life - Hospital Anxiety and Depression Scale (HADS)
Quality of life will be measured by analyzing HADS
Cardiac death and/or hospitalization for heart failure
Safety measures
Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)
Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)
Quality of life will be measured by analyzing KDQOL-SF36

Full Information

First Posted
September 19, 2012
Last Updated
August 1, 2019
Sponsor
Wuerzburg University Hospital
Collaborators
German Federal Ministry of Education and Research, Clinical Trial Center Wuerzburg (CTCW)
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1. Study Identification

Unique Protocol Identification Number
NCT01691053
Brief Title
Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
Acronym
MiREnDa
Official Title
Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
German Federal Ministry of Education and Research, Clinical Trial Center Wuerzburg (CTCW)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease / Hemodialysis
Keywords
End stage renal disease, Hemodialysis, Spironolactone, Left ventricular hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
50mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Left Ventricular Mass Index
Description
as assessed by cardiac MRI
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Cardiac function parameters
Description
cardiac volumes, systolic and diastolic function, cardiac output as measured by cardiac MRI and echocardiography
Time Frame
9 months
Title
Office and 24h blood pressure
Time Frame
9 months
Title
Clinical measures of heart failure severity
Description
New York Heart Association (NYHA) functional class, 6 minute walk test
Time Frame
9 months
Title
Vascular function
Description
Carotid intima meda thickness, pulse wave analysis, carotid artery distensibility, flow mediated dilatation of the brachial artery
Time Frame
9 months
Title
Biomarkers of heart failure, inflammation and fibrosis
Time Frame
9 months
Title
Quality of Life - Hospital Anxiety and Depression Scale (HADS)
Description
Quality of life will be measured by analyzing HADS
Time Frame
9 months
Title
Cardiac death and/or hospitalization for heart failure
Time Frame
9 months
Title
Safety measures
Description
Pre-dialysis potassium levels, frequency of hyperkalemic episodes (K>6.5mmol/l), measurement of residual kidney function (if applicable)
Time Frame
9 months
Title
Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)
Description
Quality of life will be measured by analyzing KDQOL-SF36
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Hemodialysis treatment for at least 3 months At least 3 dialysis sessions per week Written informed consent Exclusion Criteria: Contraindications for cardiac magnet resonance imaging (CMR) Mineralocorticoid receptor antagonist treatment within the last 6 months Estimated life expectancy < 12 months as judged by the nephrologist History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring ≥ 3 times within the last 3 months prior to enrolment. High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l Hypotension (systolic blood pressure < 100 mmHg) Planned kidney transplantation (living donor) within the prospected study duration Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation Allergy/hypersensitivity to spironolactone Non-compliance suspected or demonstrated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Wanner, MD
Organizational Affiliation
University Hospital Wuerzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabian Hammer, MD, PhD
Organizational Affiliation
University Hospital Wuerzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vera Krane, MD
Organizational Affiliation
University Hospital Wuerzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Hospital Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586138
Citation
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.
Results Reference
derived
PubMed Identifier
33544240
Citation
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.
Results Reference
derived
PubMed Identifier
32938484
Citation
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.
Results Reference
derived
PubMed Identifier
24166468
Citation
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.
Results Reference
derived

Learn more about this trial

Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

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