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Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

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ClinicalTrials.gov Identifier: NCT00553722
Recruitment Status : Unknown
Verified October 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 6, 2007
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Study Description
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Brief Summary:
It is well known that Aldosterone (aldo) can cause hypertension (HBP). Since aldo is known to cause the kidney to retain sodium (Na) and Na retention is known to cause HBP, it has been thought that the mechanism by which aldo causes HBP is by Na retention. Recent studies have suggested that aldo has many effects in addition to its ability to cause the kidney to retain Na. To test the hypothesis that aldo can cause HBP in a manner which does not involve Na retention, we plan, in this protocol, to give Eplerenone, a specific aldo antagonist, to patients on dialysis who have HBP. A positive effect of Eplerenone to lower HBP in these patients would support this hypothesis.

Condition or disease Intervention/treatment Phase
Hypertension Dialysis Hyperaldosteronism Drug: Eplerenone Drug: Placebo Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?
Study Start Date : November 2007
Estimated Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Eplerenone
Administer Eplerenone, 25 mg, orally twice daily for 4 weeks.
 Drug: Eplerenone
Administer Eplerenone, 25 mg,orally twice daily for 4 weeks.
Placebo Comparator: placebo
Administer a placebo tablet orally twice daily for 4 weeks
 Drug: Placebo
Administer a placebo tablet orally twice daily for 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Significant drop in blood pressure with Eplerenone when compared to placebo. [ Time Frame: days ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We will select study participants from adult hemodialysis patients treated thrice weekly at Shaare Zedek Medical Center Dialysis Unit.
  • Men and women will qualify for the study if they were on hemodialysis therapy for more than 3 months, have an average predialysis plasma potassium concentration less than 5.6 mEq/L at the time of enrollment and have nil or minimal urine output (<500 mL/24 h).
  • All participating women of childbearing age will have a negative pregnancy test result before entering into the study.

Exclusion Criteria:

Exclusion criteria will include:

  • A known allergy to Spironolactone or Eplerenone
  • Any acute illness; hypotension, defined as a predialysis systolic blood pressure less than 100 mm Hg
  • Severe hypertension (predialysis systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg)
  • Decompensated heart failure
  • Inability to give informed consent; and
  • Noncompliance.
Contacts and Locations
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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): NCT00553722


Contacts
Contact: Linda Shavit, MD 02 6555086 lshavit@szmc.org.il
Contact: Itzchak Slotki, MD o2 6555085 islotki@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Linda Shavit, MD    02 6555086    lshavit@szmc.org.il   
Principal Investigator: Linda Shavit, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Linda Shavit, MD Shaare Zedek Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00553722     History of Changes
Other Study ID Numbers: 1-Shavit
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: October 2007

Keywords provided by Shaare Zedek Medical Center:
hypertension
dialysis
hyperaldosteronism

Additional relevant MeSH terms:
Hypertension
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Eplerenone
 Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents