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Therapeutic Adherence in Uncontrolled Arterial Hypertension

Therapeutic Adherence in Uncontrolled Arterial Hypertension

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Description

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.

Eligibility

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

Study details
    Treatment Adherence

NCT04464746

Parc de Salut Mar

16 February 2024

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