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Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

NCT ID: NCT00518479

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-04-30

Brief Summary

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Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. This study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening remains to be determined. We hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment

Detailed Description

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Conditions

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Hypertension Left Ventricular Hypertrophy

Keywords

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Hypertension Left Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Neurohormonal stimulatory arm

Group Type EXPERIMENTAL

Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

Intervention Type DRUG

2

Neurohormonal inhibitory arm

Group Type EXPERIMENTAL

Valsartan 160mg OD; Moxonidine 400mcg OD

Intervention Type DRUG

Interventions

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Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

Intervention Type DRUG

Valsartan 160mg OD; Moxonidine 400mcg OD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recently diagnosed essential hypertension (within 6 months).
* Age 25 to 80 years; Weight \< 100kg.
* Sinus rhythm without significant ventricular or atrial ectopy.

Exclusion Criteria

* Current angiotensin II receptor antagonist or ACE Inhibitor treatment.
* Contra-indication to any of the protocol anti-hypertensive agents.
* Angina requiring treatment with a Beta blocker or calcium antagonist
* Any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy.
* Contraindication to MRI (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Dr JP Greenwood

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John P Greenwood, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Leeds University

Locations

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Leeds Teaching Hospital NHS Trust

Leeds, Wesst Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Burns J, Sivananthan MU, Ball SG, Mackintosh AF, Mary DA, Greenwood JP. Relationship between central sympathetic drive and magnetic resonance imaging-determined left ventricular mass in essential hypertension. Circulation. 2007 Apr 17;115(15):1999-2005. doi: 10.1161/CIRCULATIONAHA.106.668863. Epub 2007 Mar 26.

Reference Type RESULT
PMID: 17389264 (View on PubMed)

Other Identifiers

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PG/03/001

Identifier Type: -

Identifier Source: org_study_id