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Immune System Profile During Hypertensive Cardiac RemodelingNCT02165241

Immunological Profile in Relation to Cardiac Geometry in Hypertension

An observational study of Immune System Profile During Hypertensive Cardiac Remodeling, run by Neuromed IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 65 years
How many people
100 participants
Where
1 siteItaly
Study dates
Jun 2014to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • precedent acute myocardial infarction (AMI)
  • unstabile angina
  • congestive heart failure
  • hemodynamically significant valvulopathies
  • peripheric vasculopathies
  • atrioventricular conduction diseases
Show all 15Show fewer
  • 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%)

Trial locations and contacts

1 site in 1 country.

Giuseppe Lembo, prof., MD contact

0865915244

lembo@neuromed.it

Italy1 site, 1 recruiting
  • IRCCS Neuromed

    Pozzilli, (IS), 86077

    Giuseppe Lembo, prof., MD, PhD

    Giulio Selvetella, MD, PhD

    Recruiting

Other trials in Italy

About this study

Official title: Characterization of the Immunological Profile in Relation to Cardiac Geometry Variations in Hypertensive Patients

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.

Keywords
Hypertension, Cardiac remodeling, Immune system
Medical subject headings
Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Cardiac Remodeling

    Changes in left ventricular (LV) posterior wall thickness; intraventricular septum thickness (IVS); LV diameter (LVD) and Relative Wall Thickness (RWT)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02165241
Sponsor's protocol ID
LMB01
Status last verified
Apr 2022
First submitted
11 Jun 2014
Last updated
11 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Immune System Profile During Hypertensive Cardiac Remodeling, run by Neuromed IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Lembo, prof., MD (0865915244, lembo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cardiac Remodeling (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.

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