Evaluation of the Signaling Path of Emiline1-TGFβ in the Myogenic Tone of Resistance Arteries in a Population of Normotensive and Hypertensive Subjects

NCT ID: NCT02312193

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-12-31

Brief Summary

Aim of this study is to enhance the knowledge of myogenic tone alterations in hypertensive patients and to better understand the mechanisms controlling the myogenic tone. Evaluations will be performed through ex vivo studies of peripheral arterioles in human adipose tissue from lumbar muscle, isolated from biopsies. This will allow investigators to evaluate the myogenic function in response to progressive blood pressure increases, in order to correlate myogenic function to arterial hypertension and to the molecular mechanisms already identified in the preclinical models.

Conditions

Hypertension

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

Hypertensive subjects

No interventions assigned to this group

Control

Normotensive subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Males or females between 30 and 70 years of age
• Hypertensive patients: Patients with a previous diagnosis of hypertension
• Normotensive patients: subjects without story of hypertension
• Written informed consent

Exclusion Criteria

• Severe hypertension (eg, systolic >180 mm Hg, diastolic >110 mm Hg)
• Manifested or suspected secondary hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, pheochromocytoma)
• History of cardiac complications (previous acute myocardial infarction (AMI), unstabile angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), congestive heart failure (NYHA II-IV))
• Diabetes mellitus
• Renal pathologies (creatinine clearance < 30 ml/min)
• Severe hepatic dysfunction

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Lembo

MD, Ph

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Neuromed

Pozzilli, Isernia, Italy

Countries

Italy

Other Identifiers

LMB02

Identifier Type: -

Identifier Source: org_study_id