Effects of Spironolactone in Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Greicy Mara Mengue Feniman De Stefano, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01128101
First received: May 16, 2010
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Renal Failure
Drug: Spironolactone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of the Combination of Spironolactone to Conventional Pharmacotherapy in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Measurement of serum potassium and other routine laboratory parameters pertaining to the hemodialysis unit of the Hospital of the Medical School of Botucatu - UNESP.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 16, 2010
Last Updated: September 2, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014