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Completed

NCT Number: NCT04464746

Therapeutic Adherence in Uncontrolled Arterial Hypertension

In hypertension, highly prevalent, up to 10-15% of hypertensive patients have uncontrolled blood pressure despite being treated with ≥3 drugs, which is known as resistant hypertension. Resistant arterial hypertension, together with difficult-to-control hypertension, has a worse cardiovascular prognosis than controlled hypertension. In addition, data on therapeutic adherence in arterial hypertension show that 1 in 2 hypertensive patients do not fully or partially comply with the indicated therapeutic prescription. The determination of antihypertensive drugs or their metabolites in urine seems to be a good indicator of therapeutic adherence. On the other hand, the implementation of a specific program to improve knowledge of the disease and its risks and promote therapeutic adherence could improve the control of hypertension and reduce the associated morbidity and mortality.

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Key information

Conditions

Treatment Adherence Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

Objective: To assess whether the implementation of a specific action plan to improve adherence for 3 months results in reduced peripheral 24h-systolic blood pressure (SBP) in patients with resistant hypertension (RH) or uncontrolled hypertension with 2 antihypertensive drugs.

Method: interventional, prospective, randomized, controlled, parallel groups, open study of a cohort of 150 consecutively recruited patients with RH (office SBP ≥140mmHg and/or diastolic blood pressure ≥90mmHg despite treatment with ≥3 drugs at appropriate doses, one diuretic) or patients with uncontrolled hypertension with 2 antihypertensive drugs, with ambulatory 24h-BP ≥130 and / or 80mmHg. The partially or completely non-adherent patients (confirmed by determination of antihypertensive drugs in urine) will be randomized (1: 1) to receive a specific program to improve adherence (intervention group) or routine follow-up (control group), with office BP measurement and determination of antihypertensive drugs in urine at pre-randomization, 3, 6 and 12 months; peripheral and central 24h-ambulatory BP monitoring will be performed at pre-randomization, at 3 and 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged ≥18 years
  • diagnosis of resistant hypertension with treatment superior to 3 drugs at maximum dose, one of them being a diuretic
  • uncontrolled hypertension treated with 2 drugs at the maximum effective doses tolerated
  • the prescribed treatment must be stable for the last 2 months
  • given informed consent

Exclusion criteria

  • secondary arterial hypertension
  • pregnant women
  • Impossibility to perform a 24-hour blood pressure monitoring, or poor quality results.
  • Recent history of major vascular episode
  • patients receiving treatment with Barnidipino / Felodipine / Lercanidipine / Manidipine / Nifedipine / Verapamil / Eplerenone

Treatment and study plan

implementation of a specific program to improve therapeutic adherence

Other
  • Discussion of risks associated with high BP;aims,healthy lifestyle options.
  • Individualized educational intervention:verbal, written,audiovisual information. Evaluation of knowledge of prescribed drugs.
  • Behavioral counseling.training patients to participate in their own care, while positively modifying their skills or routines (i.e. pill boxes,calendars,specific measures to remind the patient taking drugs,adapt the regimen to atient's daily routine).
  • Socio-psycho-affective interventions.
  • Reminder systems: phone,email,alarm on the mobile phone.
  • Simplification as far as possible of therapeutic scheme.
  • Explanation of prescribed medications (name&dosage), correct intake.
  • Explanation of possible side effects and what to do if they happen. Facilitate a contact.
  • Advise and training on home blood pressure self-measurement.
  • Verbal, written and/or audiovisual information and the online patients'section of scientific societies addresses will be provided.

Primary outcomes

  1. Change in 24h-systolic blood pressure.

    Time frame: 3 months

    Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization

Secondary outcomes

  1. Variation in the degree of therapeutic compliance

    Time frame: 3 months

    Comparison between groups of therapeutic compliance variation according to the determination of drugs or their metabolites in urine, i.e., percentage of non-adherent patients that become fully antihypertensive treatment adherent after the implementation of the specific program to improve therapeutic adherence, as compared to the same percentage of the group who do not receive this specific program

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Official study title

Therapeutic Adherence in Uncontrolled Arterial Hypertension: Selective Detection by Urine Antihypertensive Drugs or Metabolits Analysis and Effectiveness of a Program to Improve Compliance

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2020
Registry last updated
Jun 5, 2025

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.

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