Does Aldosterone Cause Hypertension by a Non-Renal Mechanism?

NCT00553722 | Unknown Phase 4

• 1 other identifier: 1-Shavit
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Dialysis; Hyperaldosteronism

Keywords

hypertension; dialysis; hyperaldosteronism

Outcome Measures

Primary Outcomes (1)

• Significant drop in blood pressure with Eplerenone when compared to placebo.

  days

Study Arms (2)

Eplerenone

EXPERIMENTAL

Administer Eplerenone, 25 mg, orally twice daily for 4 weeks.

Drug: Eplerenone

placebo

PLACEBO COMPARATOR

Administer a placebo tablet orally twice daily for 4 weeks

Drug: Placebo

Interventions

Eplerenone DRUG

Administer Eplerenone, 25 mg,orally twice daily for 4 weeks.

Eplerenone

Placebo DRUG

Administer a placebo tablet orally twice daily for 4 weeks.

placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Linda Shavit, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Shavit, MD

CONTACT

02 6555086; lshavit@szmc.org.il

Itzchak Slotki, MD

CONTACT

o2 6555085; islotki@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Study Completion: November 1, 2009
• Last Updated: November 6, 2007

Record last verified: 2007-10

Locations

IL (1)