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Immunological Profile in Relation to Cardiac Geometry in Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02165241
First Posted: June 17, 2014
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giuseppe Lembo, Neuromed IRCCS
  Purpose

It is commonly known that heart failure (HF) is the main cause of mortality and morbidity which affects about 15 million people in the world and is the primary chronic cause of death. In spite of the development of pharmacological therapies which have led to a good control of the pathology, almost 50% of patients with advanced HF does not survive after the first year. Heart failure consists of a deterioration of the cardiac pump, whose performance become insufficient to satisfy the organism needs. HF can be the consequence of various pathologies, such as ischemia, chronic hypertension, valvulopathies, pericarditis, etc. In conditions of chronic overload, as the one induced by the cited pathologies, the cardiomyocytes reply with hypertrophy and/or death due to necrosis or apoptosis. At the same time, there is a collagen alteration which causes the substitution of the myocardial damaged portion with fibrotic material, increasing in this way cardiac rigidity and reducing contractility. Finally, the onset of inflammation, the activation of the immune system and of the inflammatory mediators affect heart functionality. These phenomena are regulated by a complex interaction between the cellular and molecular mechanisms, which moreover guarantee the homeostasis maintenance in physiological conditions. Nevertheless, their imbalance activates a complex series of events which have recently started to be recognized and studied. In effect, a recent work has underlined the importance of the splenic monocytes in the cardiac response to acute heart ischemia, changing our vision concerning the role of the immune system in heart diseases.Historically, the term "cardiac remodeling" had been introduced to describe the anatomical change of the heart which occurs after myocardial infarction. At a later stage, it has been acknowledged that also other pathological conditions, such as chronic hypertension, can be a cause of the myocardial remodeling. Physiologically, the immune system cells have always been considered for their role of protection from infections. Recently, instead, evidence have been showing that immune system cells might have far more complex functions in the heart. The myocardial remodeling comes from modifications that may be adaptive to the initial insult, but then this structural adjustment may become the activation of structural/metabolic circles which can potentially culminate in the transition to HF.

This observational study will evaluate the immunological profile in relation to cardiac geometry variations in hypertensive patients. Aim of this project is to characterize the profile of immune system activation during the process of cardiac remodeling which is typical of the cardiomyopathy of overload. The main goal will be reached through the characterization of the circulating profile of immune system cells, in order to find a correlation with the clinical phenotype.


Condition
Immune System Profile During Hypertensive Cardiac Remodeling

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization of the Immunological Profile in Relation to Cardiac Geometry Variations in Hypertensive Patients

Further study details as provided by Giuseppe Lembo, Neuromed IRCCS:

Primary Outcome Measures:
  • Changes in Cardiac Remodeling [ Time Frame: 24 months ]
    Changes in left ventricular (LV) posterior wall thickness; intraventricular septum thickness (IVS); LV diameter (LVD) and Relative Wall Thickness (RWT)


Enrollment: 100
Actual Study Start Date: June 2014
Study Completion Date: December 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be selected from the outpatient cardiac centre of the IRCCS Mediterranean Neurological Institute Neuromed, according to specific inclusion criteria. Approximately 100 subjects aged between 30 and 65 years will be included in the study. At the present 30 subjects have been enrolled.
Criteria

Inclusion Criteria:

  • Outpatients between 30 and 65 years of age
  • Subjects with a new diagnosis of hypertension not in treatment OR Subjects on antihypertensive treatment in need of further diagnostic analysis to evaluate the possibility of secondary hypertension. In this case treatment suspension will be necessary in order to obtain the ideal conditions for a diagnostic evaluation, in accordance with the guidelines for the management of arterial hypertension.
  • Absence of cardiac remodeling at the echocardiographic examination
  • Written informed consent prior to enrollment in the study

Exclusion Criteria:

  • precedent acute myocardial infarction (AMI)
  • unstabile angina
  • congestive heart failure
  • hemodynamically significant valvulopathies
  • peripheric vasculopathies
  • atrioventricular conduction diseases
  • history of atrial fibrillation or other severe arrythmias
  • malignant hypertension (200/140 mmHg)
  • renal pathologies (creatinine > 1.4 mg/dL)
  • severe respiratory diseases (COPD and allergic asthma)
  • autoimmune disorders
  • inflammatory diseases or patients with anti-inflammatory therapies
  • diabetes mellitus
  • previous and/or concomitant tumors
  • anemia (haemoglobin <10g%)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165241


Locations
Italy
IRCCS Neuromed
Pozzilli, (is), Italy, 86077
Sponsors and Collaborators
Neuromed IRCCS
  More Information

Responsible Party: Giuseppe Lembo, Professor, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02165241     History of Changes
Other Study ID Numbers: LMB01
First Submitted: June 11, 2014
First Posted: June 17, 2014
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by Giuseppe Lembo, Neuromed IRCCS:
Hypertension
Cardiac remodeling
Immune system