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
Recruitment status was Not yet recruiting
Sponsor:
Shaare Zedek Medical Center
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
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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:
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) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00553722
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 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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 September 26, 2016