Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Diagnostic
Official Title:	Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

Resource links provided by NLM:

Drug Information available for: Aldosterone Eplerenone

Genetic and Rare Diseases Information Center resources: Hyperadrenalism

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 (Child, Adult, Senior)
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

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: 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


ClinicalTrials.gov Identifier:	NCT00553722 History of Changes
Other Study ID Numbers:	1-Shavit
Study First Received:	November 5, 2007
Last Updated:	November 5, 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

ClinicalTrials.gov processed this record on June 28, 2017

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