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:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT04648592
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of primary hypertension on treatment for at least 12 months with an ACEI or ARB-II in monotherapy.
* Able to understand the study objectives and to provide written informed consent.
Exclusion Criteria:
* Severe hypertension, defined as a sitting systolic blood pressure ≥200 mmHg, a sitting diastolic blood pressure ≥115 mmHg or a maximum-minimum difference of ≥20 mmHg in systolic blood pressure or ≥10 mmHg in diastolic blood pressure between the right and left arms after three measurements on each arm.
* Suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age \<30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly,
* Treated with antihypertensive drugs other than ACEIs or ARBs.
* Use of drugs that affect diuresis or natriuresis.
* Poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or HbA1c ≥9%.
* History of cardiovascular disease, defined as acute myocardial infarction, ischemic transient attack or stroke, congestive heart failure, peripheral vascular disease or cardiac arrhythmias.
* Chronic obstructive pulmonary disease.
* Liver or kidney disease.
* Pregnant or lactating women.
* Legal incapacity or impossibility to understand the study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04648592
Study Brief:
Protocol Section:
NCT04648592