Effects of Spironolactone in Dialysis
Assessment of the Effects of the Combination of Spironolactone to Conventional Pharmacotherapy in Dialysis Patients
2 other identifiers
interventional
60
1 country
1
Brief Summary
Several studies indicate that chronic kidney disease patients give a high cardiovascular risk and have an intrinsic relationship with hypertension and cardiomyopathy: characterized by left ventricular hypertrophy and interstitial fibrosis. The reversal of left ventricular hypertrophy is associated with increased life expectancy in these patients. The renin angiotensin aldosterone system plays an important role in blood pressure control. Even patients using converting enzyme inhibitors inhibitors or angiotensin II blockers may experience the so called aldosterone breakthrough phenomenon (inappropriately called aldosterone escape). This phenomenon is documented in patients with heart disease and in chronic kidney disease. Spironolactone is a synthetic steroid that acts as an antagonist of aldosterone, which has historically avoided in chronic kidney disease patients, given the risk of hyperkalemia. However, its active metabolite, canrenone and spironolactone, are able to antagonize the binding of ouabain, a Na+/K+ATPase inhibitor, to its receptor. The Na+/K+-ATPase inhibition results in changes in sodium gradients, and increases the calcium influx through the transporter Na+/Ca+ in specific regions of the membrane. Spironolactone and canrenone in previous research were able to reverse left ventricular hypertrophy in chronic kidney disease patients on conservative treatment, which turn this drug and its metabolite potential tools for reversion of left ventricular hypertrophy in chronic kidney disease. The aim of this study is to verify the safety, tolerability and efficacy in the reversal of target organ damage from the use of spironolactone added to conventional antihypertensive therapy in chronic kidney disease patients on hemodialysis, in addition to measuring its ability to reduce left ventricular hypertrophy and arterial stiffness indices. Interventional randomized, double-blind, placebo-controlled study comprising two groups: one that will take 25mg of spironolactone associated with conventional antihypertensive therapy and another that will take spironolactone placebo associated with conventional antihypertensive therapy. Each group will consist of 30 patients. Clinical and laboratory investigations, as well as home monitoring of blood pressure, echocardiography, determination of pulse wave velocity, augmentation index, and central blood pressure measurement of serum aldosterone will be are evaluated before and after treatment that will last 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 5, 2011
September 1, 2011
1.8 years
May 16, 2010
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of Left Ventricular Hypertrophy
The reduction of left ventricular hypertrophy will be measured by echocardiography, blood pressure monitoring residential and pulse wave velocity.
12 months
Secondary Outcomes (1)
To evaluate the safety and efficacy of the use of spironolactone at a dose of 25mg in patients with chronic kidney disease on hemodialysis.
12 months
Study Arms (1)
Spironolactone
EXPERIMENTALThe group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.
Interventions
The group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.
Eligibility Criteria
You may qualify if:
- The series will consist of:
- Patients with at least 18 years of age,
- Suffering from chronic kidney disease stage V on dialysis,
- Mean blood pressure residential than 135 x 85 mm Hg and
- Who present left ventricular mass indexed for height to the 2.7 power greater than 51 g/m2, 7.
You may not qualify if:
- History or evidence of angina or myocardial infarction,
- Heart failure,
- Peripheral vascular disease,
- Hyperkalemia
- Previous valve atrial fibrillation,
- Anemia (hemoglobin \<10 g/dl),
- Doses of parathyroid hormone (PTH) greater than 300 pg/mL,
- Patients being treated with spironolactone and
- Patients who have suspended or initiated the use of inhibitors of angiotensin converting enzyme inhibitors, angiotensin receptor blockers (ARBs) renin blockers in the last six months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the Medical School of Botucatu
Botucatu, São Paulo, 18608-918, Brazil
Related Publications (3)
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.
PMID: 33586138DERIVEDFeniman De Stefano GM, Zanati-Basan SG, De Stefano LM, Silva VR, Xavier PS, Barretti P, da Silva Franco RJ, Caramori JC, Martin LC. Aldosterone is associated with left ventricular hypertrophy in hemodialysis patients. Ther Adv Cardiovasc Dis. 2016 Oct;10(5):304-13. doi: 10.1177/1753944716644583. Epub 2016 Apr 27.
PMID: 27122492DERIVEDFeniman-De-Stefano GM, Zanati-Basan SG, De Stefano LM, Xavier PS, Castro AD, Caramori JC, Barretti P, Franco RJ, Martin LC. Spironolactone is secure and reduces left ventricular hypertrophy in hemodialysis patients. Ther Adv Cardiovasc Dis. 2015 Aug;9(4):158-67. doi: 10.1177/1753944715591448. Epub 2015 Jun 26.
PMID: 26116627DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luis C Martin, Doctor
UPECLIN HC FM Botucatu Unesp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
May 16, 2010
First Posted
May 21, 2010
Study Start
March 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
September 5, 2011
Record last verified: 2011-09