Study of Adherence to Antihypertensive Drugs and Statins by Hair Analysis

NCT05347823 | Unknown DMC

• 1 other identifier: 3421CESC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arterial Hypertension; Dyslipidemias; Antihypertensive Drugs; Statins; Treatment Adherence

Outcome Measures

Primary Outcomes (2)

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

  Determination of drug concentration is used for the classification of patients as adherent or non-adherent to therapy or part of therapy based on the presence of quantifiable drugs in different segments of the hair sample representative of the time interval covered by the study

  3 months

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

  In patients who have had a prescription of statins in addition to antihypertensive drugs, their quantification in hair samples will be used to define the adherence to therapy.

  3 months

Secondary Outcomes (4)

• Comparison the results of hair analysis performed at the first and second visits.

  3 months

• Comparison of adherence to therapy in the presence of change in therapy

  3 months

• Analysis of the relationship between adherence to therapy and factors associated with the patient.

  3 months

• Assessment of the feasibility of hair analysis

  3 months

Interventions

Hair analysis for drug concentration DIAGNOSTIC_TEST

Sample collection for the determination of treatment adherence

Also known as: Blood pressure monitoring, Blood sampling

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (n=200) followed for essential hypertension at the SIIA centres 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 will be recorded along with the relevant clinical parameters and preliminarily evaluated by application of a questionnaire.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• Societa Italiana dell'Ipertensione Arteriosa: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Related Publications (17)

• UNODC, Vienna: Guidelines for Testing Drugs under International Control in Hair Sweat and Oral Fluid. https://www.unodc.org/documents/scientific/ST_NAR_30_Rev.3_Hair_Sweat_and_Oral_Fluid.pdf

  RESULT

• Bellows BK, Ruiz-Negron N, Bibbins-Domingo K, King JB, Pletcher MJ, Moran AE, Fontil V. Clinic-Based Strategies to Reach United States Million Hearts 2022 Blood Pressure Control Goals. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005624. doi: 10.1161/CIRCOUTCOMES.118.005624. Epub 2019 Jun 5.

  PMID: 31163981 RESULT

• Naderi SH, Bestwick JP, Wald DS. Adherence to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients. Am J Med. 2012 Sep;125(9):882-7.e1. doi: 10.1016/j.amjmed.2011.12.013. Epub 2012 Jun 27.

  PMID: 22748400 RESULT

• Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki RT, Varney J, Johnson JA. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ. 2006 Jul 1;333(7557):15. doi: 10.1136/bmj.38875.675486.55. Epub 2006 Jun 21.

  PMID: 16790458 RESULT

• De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.

  PMID: 14667488 RESULT

• Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002;(2):CD000011. doi: 10.1002/14651858.CD000011.

  PMID: 12076376 RESULT

• Mancia G, Rea F, Corrao G, Grassi G. Two-Drug Combinations as First-Step Antihypertensive Treatment. Circ Res. 2019 Mar 29;124(7):1113-1123. doi: 10.1161/CIRCRESAHA.118.313294.

  PMID: 30920930 RESULT

• OSMED L'uso dei farmaci in Italia Rapporto Nazionale Anno 2019 https://www.aifa.gov.it/-/rapporto-osmed-2019

  RESULT

• Weisser B, Predel HG, Gillessen A, Hacke C, Vor dem Esche J, Rippin G, Noetel A, Randerath O. Single Pill Regimen Leads to Better Adherence and Clinical Outcome in Daily Practice in Patients Suffering from Hypertension and/or Dyslipidemia: Results of a Meta-Analysis. High Blood Press Cardiovasc Prev. 2020 Apr;27(2):157-164. doi: 10.1007/s40292-020-00370-5. Epub 2020 Mar 26.

  PMID: 32219670 RESULT

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.

  PMID: 30165516 RESULT

• Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.

  PMID: 33186492 RESULT

• Scala D, Menditto E, Caruso G, Monetti VM, Orlando V, Guerriero F, Buonomo G, Caruso D, D'Avino M. Are you more concerned about or relieved by medicines? An explorative randomized study of the impact of telephone counseling by pharmacists on patients' beliefs regarding medicines and blood pressure control. Patient Educ Couns. 2018 Apr;101(4):679-686. doi: 10.1016/j.pec.2017.12.006. Epub 2017 Dec 9.

  PMID: 29249596 RESULT

• Raparelli V, Proietti M, Butta C, Di Giosia P, Sirico D, Gobbi P, Corrao S, Davi G, Vestri AR, Perticone F, Corazza GR, Violi F, Basili S. Medication prescription and adherence disparities in non valvular atrial fibrillation patients: an Italian portrait from the ARAPACIS study. Intern Emerg Med. 2014 Dec;9(8):861-70. doi: 10.1007/s11739-014-1096-1. Epub 2014 Jul 3.

  PMID: 24990547 RESULT

• Hassall D, Brealey N, Wright W, Hughes S, West A, Ravindranath R, Warren F, Daley-Yates P. Hair analysis to monitor adherence to prescribed chronic inhaler drug therapy in patients with asthma or COPD. Pulm Pharmacol Ther. 2018 Aug;51:59-64. doi: 10.1016/j.pupt.2018.07.001. Epub 2018 Jul 4.

  PMID: 29981458 RESULT

• Papaseit E, Marchei E, Mortali C, Aznar G, Garcia-Algar O, Farre M, Pacifici R, Pichini S. Development and validation of a liquid chromatography-tandem mass spectrometry assay for hair analysis of atomoxetine and its metabolites: Application in clinical practice. Forensic Sci Int. 2012 May 10;218(1-3):62-7. doi: 10.1016/j.forsciint.2011.10.012. Epub 2011 Oct 22.

  PMID: 22024657 RESULT

• Ferrari A, Licata M, Rustichelli C, Baraldi C, Vandelli D, Marchesi F, Palazzoli F, Verri P, Silingardi E. Monitoring of adherence to headache treatments by means of hair analysis. Eur J Clin Pharmacol. 2017 Feb;73(2):197-203. doi: 10.1007/s00228-016-2163-5. Epub 2016 Nov 20.

  PMID: 27866243 RESULT

• Gerona R, Wen A, Chin AT, Koss CA, Bacchetti P, Metcalfe J, Gandhi M. Quantifying Isoniazid Levels in Small Hair Samples: A Novel Method for Assessing Adherence during the Treatment of Latent and Active Tuberculosis. PLoS One. 2016 May 18;11(5):e0155887. doi: 10.1371/journal.pone.0155887. eCollection 2016.

  PMID: 27191185 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, hair samples

MeSH Terms

Conditions

Hypertension; Dyslipidemias; Treatment Adherence and Compliance

Interventions

Hair Analysis; Blood Pressure Monitoring, Ambulatory; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Monitoring, Ambulatory; Monitoring, Physiologic; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Franco Tagliaro, MD

  Univeristy of Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pietro Minuz, MD

CONTACT

3398129462; pietro.minuz@univr.it

Pietro Minuz, MD

CONTACT

0458124414; pietro.minuz@aovr.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: May 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: July 31, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

IT (1)