Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?
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| ClinicalTrials.gov Identifier: NCT00553722 |
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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
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Sponsor:
Shaare Zedek Medical Center
Information provided by:
Shaare Zedek Medical Center
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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 |
Show Detailed Description
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Eplerenone
Administer Eplerenone, 25 mg, orally twice daily for 4 weeks.
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Drug: Eplerenone
Administer Eplerenone, 25 mg,orally twice daily for 4 weeks.
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Placebo Comparator: placebo
Administer a placebo tablet orally twice daily for 4 weeks
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Drug: Placebo
Administer a placebo tablet orally twice daily for 4 weeks.
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Primary Outcome Measures :
- Significant drop in blood pressure with Eplerenone when compared to placebo. [ Time Frame: days ]
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| 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.
Information from the National Library of Medicine
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 |
| 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:
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hypertension dialysis hyperaldosteronism |
Additional relevant MeSH terms:
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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 |