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Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00553722
First received: November 5, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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 Intervention Phase
Hypertension
Dialysis
Hyperaldosteronism
 Drug: Eplerenone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

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

Estimated Enrollment: 27
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00553722     History of Changes
Other Study ID Numbers: 1-Shavit
Study First Received: November 5, 2007
Last Updated: November 5, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
hypertension
dialysis
hyperaldosteronism

Additional relevant MeSH terms:
Hyperaldosteronism
Hypertension
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
 Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013