Therapeutic Adherence in Uncontrolled Arterial Hypertension

Not Applicable

• Conditions: Treatment Adherence
• Interventions: Other: implementation of a specific program to improve therapeutic adherence

• Registration Number: NCT04464746
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2020-03-04
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-08
• Last Update Submitted: 2020-07-08
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	implementation of a specific program to improve therapeutic adherence	Implementation of a specific program to improve therapeutic adherence

Primary Outcome Measures

Name	Time	Method
Change in 24h-systolic blood pressure.	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 Outcome Measures

Name	Time	Method
Variation in the degree of therapeutic compliance	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

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain