Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07424118
Eligibility Criteria:
Inclusion Criteria \<br\>\<br\> Men and women aged 40 to 65 years. \<br\>\<br\> Confirmed diagnosis of chronic essential hypertension established at least 6 months prior to enrollment.
\<br\>\<br\> Stable antihypertensive pharmacological treatment for at least 3 months prior to enrollment, with no changes in medications or dosages.
\<br\>\<br\> Blood pressure at screening ≤ 160/100 millimeters of mercury (mmHg). \<br\>\<br\> Ability and willingness to comply with the 12-week behavioral intervention, attend scheduled coaching sessions (60-minute group sessions and 10-minute rescue sessions), perform home blood pressure monitoring, and attend clinical visits according to the study schedule.
\<br\>\<br\> Access to an electronic device with internet connectivity sufficient to participate in virtual coaching sessions and to receive and use the program digital materials.
\<br\>\<br\> Exclusion Criteria \<br\>\<br\> Secondary hypertension. \<br\>\<br\> Use of antihypertensive medications for indications other than treatment of hypertension, or use of non-oral antihypertensive therapy.
\<br\>\<br\> Medical conditions requiring mandatory continuation of antihypertensive therapy for indications other than blood pressure control, precluding medication reduction or withdrawal.
\<br\>\<br\> Physical limitation preventing participation in light-to-moderate intensity physical activity.
\<br\>\<br\> Body mass index (BMI) \< 18.5 kg/m² or clinical diagnosis of malnutrition. \<br\>\<br\> Hospitalization for any cardiovascular cause within 12 months prior to enrollment.
\<br\>\<br\> Pregnancy, breastfeeding, or planned pregnancy during the study period. \<br\>\<br\> Participation in another interventional clinical study. \<br\>\<br\> Cognitive impairment, dementia, severe psychiatric disorder, or other condition that prevents adherence to study procedures or reliable communication with the research team.
\<br\>\<br\> Alcohol or illicit substance abuse within the previous 12 months. \<br\>\<br\> Any medical condition that, in the investigator's opinion, compromises participant safety or the feasibility of medication deprescribing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07424118
Study Brief:
Protocol Section:
NCT07424118