Immunological Profile in Relation to Cardiac Geometry in Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Neuromed IRCCS
Sponsor:
Information provided by (Responsible Party):
Giuseppe Lembo, Neuromed IRCCS
ClinicalTrials.gov Identifier:
NCT02165241
First received: June 11, 2014
Last updated: June 13, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Neuromed IRCCS:

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


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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165241

Contacts
Contact: Giuseppe Lembo, prof., MD 0865915244 lembo@neuromed.it

Locations
Italy
IRCCS Neuromed Recruiting
Pozzilli, (is), Italy, 86077
Principal Investigator: Giuseppe Lembo, prof., MD, PhD         
Sub-Investigator: Giulio Selvetella, MD, PhD         
Sub-Investigator: Daniela Carnevale, PhD         
Sponsors and Collaborators
Neuromed IRCCS
  More Information

No publications provided

Responsible Party: Giuseppe Lembo, Professor, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02165241     History of Changes
Other Study ID Numbers: LMB01
Study First Received: June 11, 2014
Last Updated: June 13, 2014
Health Authority: Italy: IRCCS Neuromed Ethics Committee

Keywords provided by Neuromed IRCCS:
Hypertension
Cardiac remodeling
Immune system

ClinicalTrials.gov processed this record on October 22, 2014