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.
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
- Conditions the study is for
- Immune System Profile During Hypertensive Cardiac Remodeling
- 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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neuromed
Pozzilli, (IS), 86077
Giuseppe Lembo, prof., MD, PhD
Giulio Selvetella, MD, PhD
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.
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.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System Profile During Hypertensive Cardiac RemodelingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lembo, Neuromed IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Immunological Profile in Relation to Cardiac Geometry Variations in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02165241
- Acronym / sponsor ID
- LMB01
- Keywords
- Hypertension, Cardiac remodeling, Immune system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- precedent acute myocardial infarction (AMI)
- unstabile angina
- congestive heart failure
- hemodynamically significant valvulopathies
- peripheric vasculopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.