Therapeutic Adherence in Uncontrolled Arterial Hypertension

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

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.

Study Overview

• Status: Unknown
• Conditions: Treatment Adherence
• Intervention / Treatment: Other: implementation of a specific program to improve therapeutic adherence

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Faura, nurse; Phone Number: 0034 93 248 36 89; Email: afaura@parcdesalutmar.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital Del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; usual medical follow-up
Active Comparator: Intervention; Implementation of a specific program to improve therapeutic adherence	Other: implementation of a specific program to improve therapeutic adherence; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24h-systolic blood pressure.	Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in the degree of therapeutic compliance	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	3 months

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Fondo de Investigacion Sanitaria

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: ATHAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No