Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression
1 other identifier
interventional
42
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2003
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 17, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedAugust 16, 2012
August 1, 2012
August 17, 2007
August 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is decrease in LV mass as assessed by cardiac MRI compared between the two treatment groups.
6 months
Study Arms (2)
1
EXPERIMENTALNeurohormonal stimulatory arm
2
EXPERIMENTALNeurohormonal inhibitory arm
Interventions
Eligibility Criteria
You may qualify if:
- Recently diagnosed essential hypertension (within 6 months).
- Age 25 to 80 years; Weight \< 100kg.
- Sinus rhythm without significant ventricular or atrial ectopy.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- The Leeds Teaching Hospitals NHS Trustcollaborator
Study Sites (1)
Leeds Teaching Hospital NHS Trust
Leeds, Wesst Yorkshire, LS1 3EX, United Kingdom
Related 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. doi: 10.1161/CIRCULATIONAHA.106.668863. Epub 2007 Mar 26.
PMID: 17389264RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Greenwood, MBChB, PhD
Leeds University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
August 17, 2007
First Posted
August 20, 2007
Study Start
September 1, 2003
Study Completion
April 1, 2004
Last Updated
August 16, 2012
Record last verified: 2012-08