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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312193
• Other study ID #: LMB02
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: January 2022
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myogenic tone measured by micromyographic technique to evaluate small-artery morphology.		12 months