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NCT07589881Completed

An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)

Implementation of a Nurse-Led Educational Intervention on Adverse Effects of Antihypertensive Drugs in Patients With Resistant Hypertension: Focus on Sexual Dysfunction, Urinary Incontinence, and Qualitative Insights.

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
46 (actual)
First submitted
11 May 2026
Start date
15 Apr 2021
Primary completion date
15 Apr 2025
Lead sponsor
Consorci Sanitari Integral
NCT number
NCT07589881

What you commit to

  • Study type: Interventional
  • Participants enrolled: 46
  • From 15 Apr 2021 to the primary completion date, 15 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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).
  • Any other condition deemed inappropriate for study participation by the investigator.

Other

  • Hospitalization during the study period.
  • Participation in another clinical trial that might interfere with the study outcomes.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral
Coordinator of this site? Confirm its status
Sant Joan DespíSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.