Treatment Adherence to JNC 7(Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, 7th Report) Guidelines in Cardiovascular (CV)-Risk Patients Across the Middle East - the Impact of Ramadan Fasting on Achieving Treatment Goals in Daily Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,674
- Locations
- 132
- Primary Endpoint
- Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52
Study Overview
Brief Summary
This is an out-patient based prospective, multi-centre, observational post-marketing surveillance study amongst internists and cardiologists. In this study, patients with essential hypertension and at least one additional risk factor will be included. Patients may take any antihypertensive treatment which is approved for cardiovascular protection including Micardis 80 mg / Micardis Plus. Patients will be followed over one year in four visits from baseline to endpoint with an additional visit before and after the month of Ramadan.
Detailed Description
Purpose:
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52
Time Frame: Up to 52 weeks
The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) \<140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.
Secondary Outcomes
- Achieving JNC 7 Treatment Goals After Ramadan(1 month)
- Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)(Up to 52 weeks)
- The Overall Assessment of Treatment by Patients at 52 Weeks(Up to 52 weeks)
- Compliance of Patients During the Whole Study Duration (52 Weeks)(Up to 52 weeks)
- The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan(Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks)
- Cardiovascular Events(Up to 52 weeks)
- Compliance of Patients up to 10 Days Before Ramadan(10 days before Ramadan)
- Compliance of Patients up to 10 Days After Ramadan(10 days after Ramadan)
- Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)(Up to 52 weeks)
- The Overall Assessment of Treatment by Physicians at 52 Weeks(Up to 52 weeks)
- The Difference in Systolic Blood Pressure Before and After the Month of Ramadan(Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks)
- The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration(Up to 52 weeks)