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Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

This study has been completed.
Sponsor:
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Dr JP Greenwood, University of Leeds
ClinicalTrials.gov Identifier:
NCT00518479
First received: August 17, 2007
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Hypertension
Left Ventricular Hypertrophy
 Drug: Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD
Drug: Valsartan 160mg OD; Moxonidine 400mcg OD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1
Neurohormonal stimulatory arm
 Drug: Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD
Experimental: 2
Neurohormonal inhibitory arm
 Drug: Valsartan 160mg OD; Moxonidine 400mcg OD

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518479

Locations
United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, Wesst Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Investigators
Principal Investigator: John P Greenwood, MBChB, PhD Leeds University
  More Information

Additional Information:
Cardiac MRI Research Group - Leeds, UK  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr JP Greenwood, Senior Lecturer, University of Leeds
ClinicalTrials.gov Identifier: NCT00518479     History of Changes
Other Study ID Numbers: PG/03/001
Study First Received: August 17, 2007
Last Updated: August 15, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Leeds:
Hypertension
Left Ventricular Hypertrophy

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Moxonidine
Valsartan
Bendroflumethiazide
Amlodipine
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013