UnknownNot Applicable

Study of Adherence to Antihypertensive Drugs and Statins by Hair Analysis

Italy200 participantsStarted 2022-05-15

Plain-language summary

The problem of adherence to long-term therapies has been known for years and occurs substantially in all countries, although with greater severity in developing countries. The investigators designed a prospective open study in which 200 patients followed for hypertension at the centers of the Italian Society of Hypertension (SIIA) adhering to the project will be evaluated on the basis of their clinical characteristics, the presence of comorbidities and the therapeutic scheme in place and will be subjected to hair sampling for the analysis of drugs of interest and their possible metabolites in this matrix. The use of the prescribed drugs is recorded along with the relevant clinical parameters and preliminarily evaluated by application of a questionnaire. At the first visit, patients who have been prescribed continuously in the 3 months preceding the study the same active ingredients will be invited to participate in the study, which involves a hair sampling. They will then be prescribed the same active ingredients according to the same scheme if the blood pressure values are within the recommended limits. When more than one antihypertensive drug is present in the therapeutic scheme, they will be prescribed in a single pill, as recommended. For patients with uncontrolled blood pressure, the therapeutic scheme will be modified with the inclusion of other active ingredients and using drug combinations when possible. Patients treated with statins will continue the treatment according to clinical indication using associations with antihypertensive drugs. Patients will be examined and re-tested 3-4 months after the first visit. The use of prescribed medications will be recorded along with clinical parameters of interest and preliminarily evaluated by application of questionnaires. At each of the two visits, the investigating physician will measure blood pressure using a semi-automatic device The 24-hour blood pressure monitoring will be used. Hair extraction ad UHPLC-QQQ/MS analysis will be performed. Concentrations of active ingredient and any metabolites in the keratin matrix are expressed in ng or fractions of ng/mg.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients older than 18 years of both sexes with a diagnosis of hypertension undergoing treatment for at least 3 months with antihypertensive drugs and also statins. * Diagnosis of secondary forms of hypertension excluded. * Subjects who express their willingness to participate in the study by signing the consent form having understood the content of the written and verbal information provided about the purpose and mode of execution of the study. Exclusion Criteria: * Subjects unable to express voluntary adherence to the study. * Renal insufficiency with estimated glomerular filtrate less than 50 mL/minute- * Heart failure with functional class equal to or greater than II. * Chronic inflammatory disease. * Neoplastic disease. * Any chronic diseases requiring continuous treatment with drugs known to interact pharmacokinetically with the antihypertensive drugs being monitored.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determination of the concentration of antihypertensive drugs in hair samples collected at the first and second visits

Timeframe: 3 months

Determination of the concentration of statins prescribed to patient in hair samples collected at the first and second visits

Timeframe: 3 months

Trial details

NCT IDNCT05347823

SponsorAzienda Ospedaliera Universitaria Integrata Verona

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-30

Contact for this trial

Pietro Minuz, MD

3398129462 pietro.minuz@univr.it

View on ClinicalTrials.gov More Arterial Hypertension trials