We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518479
First Posted: August 20, 2007
Last Update Posted: August 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Leeds Teaching Hospitals NHS Trust
Information provided by (Responsible Party):
Dr JP Greenwood, University of Leeds
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Resource links provided by NLM:


Further study details as provided by Dr JP Greenwood, 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: August 17, 2007
First Posted: August 20, 2007
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Dr JP Greenwood, 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
Amlodipine
Valsartan
Bendroflumethiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors