Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01853839
First received: May 13, 2013
Last updated: July 15, 2015
Last verified: July 2015
  Purpose

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.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Achieving JNC 7 Treatment Goals After Ramadan [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. 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.

  • Cardiovascular Events [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    Percentage of participants who experienced a major cardiovascular (CV) event

  • The Overall Assessment of Treatment by Patients at 52 Weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.

  • The Overall Assessment of Treatment by Physicians at 52 Weeks [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.

  • Compliance of Patients up to 10 Days Before Ramadan [ Time Frame: 10 days before Ramadan ] [ Designated as safety issue: No ]
    Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".

  • Compliance of Patients up to 10 Days After Ramadan [ Time Frame: 10 days after Ramadan ] [ Designated as safety issue: No ]
    Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".

  • Compliance of Patients During the Whole Study Duration (52 Weeks) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from "none of the time" to "all of the time".

  • Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)

  • The Difference in Systolic Blood Pressure Before and After the Month of Ramadan [ Time Frame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in systolic blood pressure before and after the month of Ramadan

  • The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan [ Time Frame: Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in diastolic blood pressure before and after the month of Ramadan

  • The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    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 the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. 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. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.

  • Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.


Enrollment: 1674
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Purpose:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypertensive patients wih at least one CV risk factor

Criteria

Inclusion criteria:

  1. Male or female of age 18 years or older;
  2. Newly diagnosed and untreated or previously treated and uncontrolled patients with essential hypertension;
  3. Seated blood pressure of >140/90 mmHg or >130/80 mmHg in patients with diabetes mellitus or chronic kidney disease;
  4. Patients with at least one cardiovascular (cv) risk factor;
  5. Ability to provide written informed consent.

Exclusion criteria:

  1. Patients with contraindications to the prescribed antihypertensive medications;
  2. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
  3. Patients who are participating in any other study protocol.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01853839

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01853839     History of Changes
Other Study ID Numbers: 502.602
Study First Received: May 13, 2013
Results First Received: July 15, 2015
Last Updated: July 15, 2015
Health Authority: Algeria: Ministry of Health
Egypt: Ministry of Health and Population
Lebanon: Ministry of Public Health
Saudi Arabia: Ministry of Health
United Arab Emirates: Drug Cont Dept-Med&Pharm Cont-Ministry of Health

ClinicalTrials.gov processed this record on August 30, 2015