Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Not Applicable

Completed

• Conditions: Hypertension; Left Ventricular Hypertrophy
• Interventions: Drug: Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD; Drug: Valsartan 160mg OD; Moxonidine 400mcg OD

• Registration Number: NCT00518479
• Lead Sponsor: University of Leeds

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2004-04
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-20
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD	Neurohormonal stimulatory arm
2	Valsartan 160mg OD; Moxonidine 400mcg OD	Neurohormonal inhibitory arm

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.	6 months

Trial Locations

Locations (1)

Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, Wesst Yorkshire, United Kingdom