Study MIPAE - Melatonin and Essential Arterial Hypertension

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Caucasian race;

• Age 40-50;

• Signed written informed consent

• Normal weight;

• Blood pressure: PAD >90 mmHg and PAS >140 mmHg;

• Blood pressure in the above mentioned range from at least 1 years

• Fasting blood sugar < 100 mg/dL;

• Total cholesterol < 200 mg/dL and triglycerides < 150 mg/dL;

• Intake of antihypertensive therapies (except nitrates, statins and β-blockers);

• Non-smoking;

• No night shift workers (at least in the last 3 months before recruitment);

• With a regular sleep/wake rhythm;

• No pregnant/nursing women.

Exclusion Criteria:

• Blood pressure: PAD <90 mmHg and PAS <140 mmHg

• Heart disease of any kind;

• Autoimmune or rheumatological or vascular diseases other than essential hypertension;

• Anti-hypertensive therapies with nitrates, statins or β-blockers;

• Pregnancy/nursing;

• < 40 or > 50 years;

• Worker with night shifts (for a period of less than 3 months before recruitment);

• Continuous irregular sleep/wake rhythm.