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OpenTrials
Completed

NCT Number: NCT00518479

Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

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

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Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospital NHS Trust

Leeds, Wesst Yorkshire, LS1 3EX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bendroflumethiazide 2.5mg OD; Amlodipine 10mg OD

Drug

Valsartan 160mg OD; Moxonidine 400mcg OD

Drug

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • The Leeds Teaching Hospitals NHS Trust

Registry information

Important dates

Study start
2003
Study completion
2004
First posted
Aug 20, 2007
Registry last updated
Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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