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Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

This study has been completed.
Information provided by:
West Penn Allegheny Health System Identifier:
First received: October 23, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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.

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

Inclusion Criteria:

  • hemodialysis patients

Exclusion Criteria:

  • non compliance
  • hyperkalemia
  • pregnancy
  • expected survival less than 9 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT00548912

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
West Penn Allegheny Health System
Principal Investigator: Richard Marcus West Penn Allegheny Health System
  More Information Identifier: NCT00548912     History of Changes
Other Study ID Numbers: RC-3267
Study First Received: October 23, 2007
Last Updated: October 23, 2007

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Hypertrophy, Left Ventricular
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on August 22, 2017