NCT00138944

Brief Summary

Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon. During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage. Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

August 29, 2005

Last Update Submit

April 16, 2013

Conditions

Essential Hypertension

Keywords

Essential hypertension

Outcome Measures

Primary Outcomes (1)

  • Change of left ventricular mass

    MRT assessment of left ventricular mass

    3 months vs. baseline

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: placebo

2

ACTIVE COMPARATOR

Eplerenone

Drug: eplerenone

Interventions

placeboDRUG

od

1
eplerenoneDRUG

50mg od

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Casual blood pressure \>=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic

You may not qualify if:

  • Contraindication for eplerenone
  • Creatinine-Clearance \< 60 ml/min
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRC Medical Department IV

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Roland E Schmieder, MD

    University Erlangen-Nuremberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

DE(1)