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Effects of Spironolactone in Dialysis

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ClinicalTrials.gov Identifier: NCT01128101
Recruitment Status : Unknown
Verified September 2011 by Greicy Mara Mengue Feniman De Stefano, UPECLIN HC FM Botucatu Unesp.
Recruitment status was:  Recruiting
First Posted : May 21, 2010
Last Update Posted : September 5, 2011
Sponsor:
Information provided by (Responsible Party):
Greicy Mara Mengue Feniman De Stefano, UPECLIN HC FM Botucatu Unesp

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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: Spironolactone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of the Combination of Spironolactone to Conventional Pharmacotherapy in Dialysis Patients
Study Start Date : March 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Spironolactone
The group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.
Drug: Spironolactone
The group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.



Primary Outcome Measures :
  1. Reduction of Left Ventricular Hypertrophy [ Time Frame: 12 months ]
    The reduction of left ventricular hypertrophy will be measured by echocardiography, blood pressure monitoring residential and pulse wave velocity.


Secondary Outcome Measures :
  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. [ Time Frame: 12 months ]
    Measurement of serum potassium and other routine laboratory parameters pertaining to the hemodialysis unit of the Hospital of the Medical School of Botucatu - UNESP.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The series will consist of:

  1. Patients with at least 18 years of age,
  2. Suffering from chronic kidney disease stage V on dialysis,
  3. Mean blood pressure residential than 135 x 85 mm Hg and
  4. Who present left ventricular mass indexed for height to the 2.7 power greater than 51 g/m2, 7.

Exclusion Criteria:

  1. History or evidence of angina or myocardial infarction,
  2. Heart failure,
  3. Peripheral vascular disease,
  4. Hyperkalemia
  5. Previous valve atrial fibrillation,
  6. Anemia (hemoglobin <10 g/dl),
  7. Doses of parathyroid hormone (PTH) greater than 300 pg/mL,
  8. Patients being treated with spironolactone and
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128101


Contacts
Contact: Greicy Mara M Feniman De Stefano, MSc 55 14 3811-6213 gmmfds@yahoo.com.br
Contact: Luis C Martin, Dr 55 14 3811-6213 cuadrado@fmb.unesp.br

Locations
Brazil
Hospital of the Medical School of Botucatu Recruiting
Botucatu, São Paulo, Brazil, 18608-918
Contact: Greicy M Feniman De Stefano, MSc    55 14 3811-6213    gmmfds@yahoo.com.br   
Contact: Luis C Martin, Dr    55 14 3811-6213    cuadrado@fmb.unesp.br   
Principal Investigator: Greicy Mara M Feniman De Stefano, MSc         
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Study Director: Luis C Martin, Doctor UPECLIN HC FM Botucatu Unesp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greicy Mara Mengue Feniman De Stefano, MSc, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01128101     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-43
3439-2010 ( Other Identifier: Research Ethics Committee - Unesp )
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011

Keywords provided by Greicy Mara Mengue Feniman De Stefano, UPECLIN HC FM Botucatu Unesp:
spironolactone
chronic kidney disease
dialysis
LHV

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents