Study MIPAE - Melatonin and Essential Arterial Hypertension
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
Study MIPAE - Melatonin and essential arterial hypertension.
Study with dietary supplement, prospective and monocentric (randomized control trial). 1
mg/day of melatonin has been administered for one year to a group of patients suffering from
essential hypertension (from at least one year) and who are already on antihypertensive
therapy. This group has been compared with as many hypertensive patients on antihypertensive
therapy to whom melatonin has not been administered. Each of the participants have been
evaluated at the beginning of the study and after one year considering:
- systolic and diastolic blood pressure;
- echocardiographic values (Vivid Q, GE Healthcare);
- applanation tonometry (SphygmoCor, AtCor Medical);
- peripheral arterial tonometry (EndoPAT-2000, Itamar);
- melatonin levels and total circulating antioxidant capacity after peripheral venous
blood sampling.
The aim of the study was to evaluate the antioxidant and vasoprotective effects of melatonin,
evaluating both plasma changes and directly studying the possibility of a real remodeling and
improvement of cardiac structures.
Phase:
Phase 2
Details
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia