<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464746</url>
  </required_header>
  <id_info>
    <org_study_id>ATHAN</org_study_id>
    <nct_id>NCT04464746</nct_id>
  </id_info>
  <brief_title>Therapeutic Adherence in Uncontrolled Arterial Hypertension</brief_title>
  <official_title>Therapeutic Adherence in Uncontrolled Arterial Hypertension: Selective Detection by Urine Antihypertensive Drugs or Metabolits Analysis and Effectiveness of a Program to Improve Compliance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondo de Investigacion Sanitaria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Parc de Salut Mar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In hypertension, highly prevalent, up to 10-15% of hypertensive patients have uncontrolled&#xD;
      blood pressure despite being treated with ≥3 drugs, which is known as resistant hypertension.&#xD;
      Resistant arterial hypertension, together with difficult-to-control hypertension, has a worse&#xD;
      cardiovascular prognosis than controlled hypertension. In addition, data on therapeutic&#xD;
      adherence in arterial hypertension show that 1 in 2 hypertensive patients do not fully or&#xD;
      partially comply with the indicated therapeutic prescription. The determination of&#xD;
      antihypertensive drugs or their metabolites in urine seems to be a good indicator of&#xD;
      therapeutic adherence. On the other hand, the implementation of a specific program to improve&#xD;
      knowledge of the disease and its risks and promote therapeutic adherence could improve the&#xD;
      control of hypertension and reduce the associated morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To assess whether the implementation of a specific action plan to improve&#xD;
      adherence for 3 months results in reduced peripheral 24h-systolic blood pressure (SBP) in&#xD;
      patients with resistant hypertension (RH) or uncontrolled hypertension with 2&#xD;
      antihypertensive drugs.&#xD;
&#xD;
      Method: interventional, prospective, randomized, controlled, parallel groups, open study of a&#xD;
      cohort of 150 consecutively recruited patients with RH (office SBP ≥140mmHg and/or diastolic&#xD;
      blood pressure ≥90mmHg despite treatment with ≥3 drugs at appropriate doses, one diuretic) or&#xD;
      patients with uncontrolled hypertension with 2 antihypertensive drugs, with ambulatory 24h-BP&#xD;
      ≥130 and / or 80mmHg. The partially or completely non-adherent patients (confirmed by&#xD;
      determination of antihypertensive drugs in urine) will be randomized (1: 1) to receive a&#xD;
      specific program to improve adherence (intervention group) or routine follow-up (control&#xD;
      group), with office BP measurement and determination of antihypertensive drugs in urine at&#xD;
      pre-randomization, 3, 6 and 12 months; peripheral and central 24h-ambulatory BP monitoring&#xD;
      will be performed at pre-randomization, at 3 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Interventional, prospective, randomized, controlled, parallel groups, open study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients are not knowledged whether they are allocated to the control group or to the interventional group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24h-systolic blood pressure.</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation in the degree of therapeutic compliance</measure>
    <time_frame>3 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Treatment Adherence</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual medical follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implementation of a specific program to improve therapeutic adherence</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>implementation of a specific program to improve therapeutic adherence</intervention_name>
    <description>Discussion of risks associated with high BP;aims,healthy lifestyle options.&#xD;
Individualized educational intervention:verbal, written,audiovisual information. Evaluation of knowledge of prescribed drugs.&#xD;
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).&#xD;
Socio-psycho-affective interventions.&#xD;
Reminder systems: phone,email,alarm on the mobile phone.&#xD;
Simplification as far as possible of therapeutic scheme.&#xD;
Explanation of prescribed medications (name&amp;dosage), correct intake.&#xD;
Explanation of possible side effects and what to do if they happen. Facilitate a contact.&#xD;
Advise and training on home blood pressure self-measurement.&#xD;
Verbal, written and/or audiovisual information and the online patients'section of scientific societies addresses will be provided.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged ≥18 years&#xD;
&#xD;
          -  diagnosis of resistant hypertension with treatment superior to 3 drugs at maximum&#xD;
             dose, one of them being a diuretic&#xD;
&#xD;
          -  uncontrolled hypertension treated with 2 drugs at the maximum effective doses&#xD;
             tolerated&#xD;
&#xD;
          -  the prescribed treatment must be stable for the last 2 months&#xD;
&#xD;
          -  given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary arterial hypertension&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  Impossibility to perform a 24-hour blood pressure monitoring, or poor quality results.&#xD;
&#xD;
          -  Recent history of major vascular episode&#xD;
&#xD;
          -  patients receiving treatment with Barnidipino / Felodipine / Lercanidipine /&#xD;
             Manidipine / Nifedipine / Verapamil / Eplerenone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anna Faura, nurse</last_name>
    <phone>0034 93 248 36 89</phone>
    <email>afaura@parcdesalutmar.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Parc de Salut Mar</investigator_affiliation>
    <investigator_full_name>Anna Oliveras</investigator_full_name>
    <investigator_title>Head of Hypertension &amp; Vascular Risk Unit. Nephrology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464746
org study id: ATHAN
nct id: NCT04464746
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Interventional, prospective, randomized, controlled, parallel groups, open study
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients are not knowledged whether they are allocated to the control group or to the interventional group
measure: Change in 24h-systolic blood pressure.
time frame: 3 months
description: Comparison between groups of change in 24-hour-systolic blood pressure provided by 24h-ambulatory blood pressure monitoring 3 months after randomization
measure: Variation in the degree of therapeutic compliance
time frame: 3 months
description: 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
arm group label: Control
arm group type: No Intervention
description: usual medical follow-up
arm group label: Intervention
arm group type: Active Comparator
description: Implementation of a specific program to improve therapeutic adherence
intervention type: Other
intervention name: implementation of a specific program to improve therapeutic adherence
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna Faura, nurse
phone: 0034 93 248 36 89
email: afaura@parcdesalutmar.cat
facility: 
status: Recruiting
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Parc de Salut Mar
investigator full name: Anna Oliveras
investigator title: Head of Hypertension & Vascular Risk Unit. Nephrology Department
mesh term: Hypertension
sharing ipd: No