Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: placebo; Drug: eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT00138944

KFO_TP5/2

DFG KFO 106-2 TP5

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 85 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

2

Active Comparator group

Description:

Eplerenone

Treatment:

Drug: eplerenone