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NCT05347823: INNOVA
Study of Adherence to Antihypertensive Drugs and Statins by Hair Analysis
trial testing Hair analysis for drug concentration in Arterial Hypertension in 200 participants. Status unknown.
30 December 2022
Quick facts
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 15 May 2022 |
| Primary completion | 30 December 2022 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Hair analysis for drug concentration
Conditions studied
- Arterial Hypertension — all drugs for Arterial Hypertension →
- Dyslipidemias — all drugs for Dyslipidemias →
- Antihypertensive Drugs — all drugs for Antihypertensive Drugs →
- Statins — all drugs for Statins →
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona — full company profile →
Who can join
Adults 18 to 99, any sex, with Arterial Hypertension or Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05347823
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05347823 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliera Universitaria Integrata Verona
- Last refreshed: 2 May 2022
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