Japan Morning Surge-1 Study
This study has been completed.
Sponsor:
Japan Heart Foundation
Information provided by:
Japan Heart Foundation
ClinicalTrials.gov Identifier:
NCT00285519
First received: January 24, 2006
Last updated: February 1, 2006
Last verified: February 2006
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Purpose
The purpose of this study is to examine whether strict blood pressure (BP) control by doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce hypertensive target organ damage.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Doxazosin (drug) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of Controlling Morning Hypertension on Target Organ Damage With Adrenergic Blockers, Based on Self-Measured Morning Blood Pressure Readings |
Resource links provided by NLM:
Further study details as provided by Japan Heart Foundation:
Primary Outcome Measures:
- brain natriuretic peptide and the urinary albumin excretion/creatinine ratio at 6 months
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | August 2005 |
Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.We will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Morning systolic blood pressure >135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months
Exclusion Criteria:
- History of heart failure
- Presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease
- Taking an alfa-blocker or beta-blocker
- Atrial fibrillation or atrial flutter
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285519
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285519
Locations
| Japan | |
| Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine | |
| Shimotsuke, Tochigi, Japan, 329-0498 | |
Sponsors and Collaborators
Japan Heart Foundation
Investigators
| Study Chair: | Kazuomi Kario, MD, PhD | Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00285519 History of Changes |
| Other Study ID Numbers: |
JHF-03-143 |
| Study First Received: | January 24, 2006 |
| Last Updated: | February 1, 2006 |
Keywords provided by Japan Heart Foundation:
|
Morning hypertension |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Doxazosin Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists |
Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 25, 2017