Skip to main content
OpenTrials
Completed

NCT Number: NCT01853839

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 106, Algiers, Algeria

Loading trial locations.

About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patients with contraindications to the prescribed antihypertensive medications;
  • Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception;
  • Patients who are participating in any other study protocol.

Treatment and study plan

Primary outcomes

  1. 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

  1. Achieving JNC 7 Treatment Goals After Ramadan

    Time frame: 1 month

    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.

  2. Cardiovascular Events

    Time frame: Up to 52 weeks

    Percentage of participants who experienced a major cardiovascular (CV) event

  3. The Overall Assessment of Treatment by Patients at 52 Weeks

    Time frame: Up to 52 weeks

    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.

  4. The Overall Assessment of Treatment by Physicians at 52 Weeks

    Time frame: Up to 52 weeks

    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.

  5. Compliance of Patients up to 10 Days Before Ramadan

    Time frame: 10 days before Ramadan

    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".

  6. Compliance of Patients up to 10 Days After Ramadan

    Time frame: 10 days after Ramadan

    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".

  7. Compliance of Patients During the Whole Study Duration (52 Weeks)

    Time frame: Up to 52 weeks

    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".

  8. 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

    Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)

  9. 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

    Change from baseline in systolic blood pressure before and after the month of Ramadan

  10. 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

    Change from baseline in diastolic blood pressure before and after the month of Ramadan

  11. The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration

    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 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.

  12. 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

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 15, 2013
Registry last updated
Aug 10, 2015

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.

Published trials that share one or more normalized conditions with this study.