Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Hypertension Clinical Trial

Official title:

Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518479
• Other study ID #: PG/03/001
• Status: Completed
• Phase: N/A
• First received: August 17, 2007
• Last updated: August 15, 2012
• Start date: September 2003
• Est. completion date: April 2004

Study information

• Verified date: August 2012
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Drug:
• Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

• Valsartan 160mg OD; Moxonidine 400mcg OD

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds	Wesst Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.		6 months	No

External Links

•   Cardiac MRI Research Group - Leeds, UK