Treatment AdherenceNCT04464746
Therapeutic Adherence in Uncontrolled Arterial Hypertension
A study testing implementation of a specific program to improve therapeutic adherence in people with Treatment Adherence, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- implementation of a specific program to improve therapeutic adherence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Treatment Adherence
- Being tested
- implementation of a specific program to improve therapeutic adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of a specific program to improve therapeutic adherenceOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual medical follow-up |
| Intervention | Active comparator | Implementation of a specific program to improve therapeutic adherence Receives: Other: implementation of a specific program to improve therapeutic adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2018
- Primary completion20 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, randomized, controlled, parallel groups, open study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Anna Oliveras, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464746
- Sponsor's protocol ID
- ATHAN
- Status last verified
- Jun 2025
- First submitted
- 4 Mar 2020
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveras A, Vazquez S, Vega MV, Camps C, Illana FJ, Armario P, Crespo M, de la Sierra A. Improvement of non-adherence and reduction of BP values in patients with difficult-to-treat hypertension: the ATHAN clinical trial. Hypertens Res. 2024 Oct;47(10):2864-2873. doi: 10.1038/s41440-024-01748-x. Epub 2024 Jul 31.
PubMed 39085464
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04464746
- Acronym / sponsor ID
- ATHAN
- Conditions
- Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional, prospective, randomized, controlled, parallel groups, open study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual medical follow-up |
| Intervention | Active comparator | Other: implementation of a specific program to improve therapeutic adherenceImplementation of a specific program to improve therapeutic adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation of a specific program to improve therapeutic adherence1. Discussion of risks associated with high BP;aims,healthy lifestyle options. 2. Individualized educational intervention:verbal, written,audiovisual information. Evaluation of knowledge of prescribed drugs. 3. 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). 4. Socio-psycho-affective interventions. 5. Reminder systems: phone,email,alarm on the mobile phone. 6. Simplification as far as possible of therapeutic scheme. 7. Explanation of prescribed medications (name\&dosage), correct intake. 8. Explanation of possible side effects and what to do if they happen. Facilitate a contact. 9. Advise and training on home blood pressure self-measurement. 10. Verbal, written and/or audiovisual information and the online patients'section of scientific societies addresses will be provided. | Other | Intervention |
Primary outcome
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
1 secondary outcome
Variation in the degree of therapeutic compliance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 39085464Oliveras A, Vazquez S, Vega MV, Camps C, Illana FJ, Armario P, Crespo M, de la Sierra A. Improvement of non-adherence and reduction of BP values in patients with difficult-to-treat hypertension: the ATHAN clinical trial. Hypertens Res. 2024 Oct;47(10):2864-2873. doi: 10.1038/s41440-024-01748-x. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation of a specific program to improve therapeutic adherence in people with Treatment Adherence, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24h-systolic blood pressure. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04464746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.