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

January 3, 2022 updated by: Giuseppe Lembo, Neuromed IRCCS
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Isernia
      • Pozzilli, Isernia, Italy, 86077
        • IRCCS Neuromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be selected from patients hospitalized in the Department of Neurosurgery of the IRCCS Mediterranean Neurological Institute Neuromed, according to specific inclusion criteria and undergoing surgery for disc disease. Subjects included in the study will be normotensive and hypertensive patients. Approximately 70 subjects of both genders (35 normotensive, 35 hypertensive) aged between 30 and 70 years old will be included in the study. All the enrolled patients must have an indication for neurosurgical intervention.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Case
Hypertensive subjects
Control
Normotensive subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myogenic tone measured by micromyographic technique to evaluate small-artery morphology.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMB02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe