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Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548912
First Posted: October 24, 2007
Last Update Posted: October 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
West Penn Allegheny Health System
  Purpose
The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass

Condition Intervention Phase
Kidney Failure, Chronic Drug: Spironolactone Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • Left ventricular mass [ Time Frame: 9 months ]

Detailed Description:
Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • hemodialysis patients

Exclusion Criteria:

  • non compliance
  • hyperkalemia
  • pregnancy
  • expected survival less than 9 months
  Contacts and Locations
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): NCT00548912


Locations
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Richard Marcus West Penn Allegheny Health System
  More Information

ClinicalTrials.gov Identifier: NCT00548912     History of Changes
Other Study ID Numbers: RC-3267
First Submitted: October 23, 2007
First Posted: October 24, 2007
Last Update Posted: October 24, 2007
Last Verified: October 2007

Keywords provided by West Penn Allegheny Health System:
Kidney Failure, Chronic
Hemodialysis
Spironolactone

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Hypertrophy, Left Ventricular
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Hypertrophy
Pathological Conditions, Anatomical
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents