Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01893788

Acronym

EARTH

Enrollment

100

Registered

2013-07-09

Start date

2013-04-30

Completion date

Unknown

Last updated

2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Left Ventricular Hypertrophy

Keywords

hypertension, left ventricular hypertrophy, renin angiotensin system, aldosterone, aliskiren, eplerenone, P3NP

Brief summary

The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.

Interventions

DRUGAliskiren

Aliskiren: 150 to 300 mg daily for 48 weeks

DRUGEplerenone

50 to 100 mg daily for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

Male or female ≧ 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent

Exclusion criteria

1. History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months. 2. Planned to taking percutaneous coronary intervention and coronary artery bypass graft 3. Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension. 4. History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months 5. Severe valvular heart disease or atrial fibrillation 6. Congenital heart disease 7. Severe heart failure (NYHA functional class Ⅳ) 8. Current treatment with aliskiren or eplerenone or diuretics 9. Taking potassium preparation or potassium-sparing diuretic 10. Estimated GFR ≦ 30ml/min/1.73m２ at screening or current treatment with hemodialysis 11. Potassium \> 5.0mEq/L at screening 12. Diabetes mellitus with microalbuminuria or albuminuria 13. Impairment of liver function (liver failure, liver cirrhosis) 14. Pregnant woman or possibly pregnant woman 15. History of malignant tumor include hematological neoplasm 16. Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir 17. Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone 18. Current participation in another clinical trial 19. Serious non-cardiovascular disease severely limiting life expectancy 20. Contra-indication to MRI

Design outcomes

Primary

Measure	Time frame	Description
reduction of left ventricular hypertrophy measured by magnetic resonance imaging	12 month	To compare the 12 month left ventricular mass or left ventricular mass and index measured by magnetic resonance imaging with baseline.

Secondary

Measure	Time frame	Description
Cardiovascular events	12 month	total death, composite cardiovascular events, cardiac function eveluated by UCG,reduction of left ventricular hypertrophy measured by UCG

Other

Measure	Time frame	Description
Biochemical parameters	12 month	BNP, PIIINP etc

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026