An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension… (NCT07589881) | Clinical Trial Compass
CompletedNot Applicable
An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)
Spain46 participantsStarted 2021-04-15
Plain-language summary
This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 75 years.
* Diagnosis of resistant hypertension, defined as blood pressure not controlled despite the use of three or more antihypertensive medications.
* Uncontrolled blood pressure as measured by ambulatory blood pressure monitoring (ABPM).
* Resistant hypertension not secondary to other medical conditions (i.e., primary or essential hypertension).
* No use of antihypertensive medications other than the prescribed ones, and no intake of licorice (which can interfere with blood pressure).
Exclusion Criteria:
* Secondary causes of hypertension (e.g., endocrine disorders like hyperaldosteronism, pheochromocytoma, etc.).
* Severe cognitive impairment that would prevent the patient from understanding the intervention or providing informed consent.
* Uncontrolled psychiatric conditions that would interfere with participation (e.g., severe depression or psychosis).
* Hospitalization during the study period.
* Change of treatment regimen antihypertensive by a physician outside the study team (e.g., switching antihypertensive drugs or adding new medications without prior consultation with the study team).
* Participation in another clinical trial that might interfere with the study outcomes.
* Any other condition deemed inappropriate for study participation by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention
Timeframe: Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program.