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Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Primary Purpose

Hypertension, Left Ventricular Hypertrophy

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

Valsartan 160mg OD; Moxonidine 400mcg OD

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Left Ventricular Hypertrophy

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Leeds Teaching Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Neurohormonal stimulatory arm

Neurohormonal inhibitory arm

Outcomes

Primary Outcome Measures

The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.

Secondary Outcome Measures

Full Information

NCT ID

NCT00518479

First Posted

August 17, 2007

Last Updated

August 15, 2012

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT00518479

Brief Title

Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Official Title

Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Left Ventricular Hypertrophy

Keywords

Hypertension, Left Ventricular Hypertrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Neurohormonal stimulatory arm

Arm Title

Arm Type

Experimental

Arm Description

Neurohormonal inhibitory arm

Intervention Type

Drug

Intervention Name(s)

Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

Intervention Type

Drug

Intervention Name(s)

Valsartan 160mg OD; Moxonidine 400mcg OD

Primary Outcome Measure Information:

Title

The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Greenwood, MBChB, PhD

Organizational Affiliation

Leeds University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Leeds Teaching Hospital NHS Trust

City

Leeds

State/Province

Wesst Yorkshire

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

17389264

Citation

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.

Results Reference

result

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Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

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