Heart FailureFATENCT06343233
FAiling HearT in the Elderly (FATE) Study
An observational study of Heart Failure and Frailty, run by IRCCS Multimedica at 7 sites in Italy.
Trial summary
In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Frailty
- How many people
- 5,000 participants
- Where
- 7 sitesItaly
- Study dates
- 19 Nov 2019to Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years or older hospitalized for acute decompensated heart failure (ADHF). The index event must be documented, at the time of discharge, by the need for intravenous administration of specific treatments and classified based on the International Classification of Diseases (ICD-9 code 428 or codes consistent with the presence of any heart failure, for primary or secondary disease).
Who may be able to join
- Patients aged > 65 years;
- Patients hospitalized for acute heart failure;
- Signature of informed consent.
Who cannot join
- Patients with significant valvular pathology at T0/Baseline (index event);
- Patients with malignant neoplasms or systemic pathology with a prognosis "quoad vitam" less than 1 year;
- Patients with known active infectious diseases.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Ospedale Policlinico San Martino IRCCS
Genova, 16132
Pietro Ameri, MD, +39 0103538928, pietroameri@unige.it
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, MIlano, 20138
PierGiuseppe Agostoni, MD, +39 02 58002772, piergiuseppe.agostoni@unimi.it
- Not yet recruiting
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Milan, 20100
Marco Vicenzi, MD, +39 02 503 20512, marco.vicenzi@unimi.it
- Recruiting
IRCCS Auxologico
Milan, 20149
Gianluca Caldara, MD, +39 02 61911 251, g.caldara@auxologico.it
- Recruiting
Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)
Montescano, Italy/Pavia, 27040
Maria Teresa La Rovere, MD, +39 0385 247290, mariateresa.larovere@icsmaugeri.it
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089
Cristina Panico, MD, +39 0282241, cristina.panico@humanitas.it
- Recruiting
IRCCS MultiMedica
Sesto San Giovanni, Milano, 20099
Gaia Cattadori, MD, +39 02 8687 8889, gaia.cattadori@multimedica.it
About this study
Official title: Multicenter, Prospective Observational Study of Patients Aged 65 Years or Older, Hospitalized for Acute Heart Failure.
In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.
The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.
Read the detailed description
Heart failure is a clinical condition continuously growing, characterized by an unfavorable prognosis both in terms of life and health. It is increasingly common and often associated with other clinical conditions that complicate its course, worsen the prognosis, and increase costs for the National Health Service (NHS). Heart failure (HF) is characterized by high prevalence (3% of the adult population, approximately 600,000 patients already diagnosed in Italy) and incidence (0.1-0.2, 87,000 cases/year). Patients with chronic HF may experience disease exacerbations leading to frequent hospitalizations, which, however, are appropriate in only a minority of cases.
Heart failure is a leading cause of death and hospitalization, especially in patients over 65 years of age. The annual incidence of heart failure doubles for every decade over 65 years, with a prevalence reaching 10% in patients over 80 years of age. Age is also one of the major determinants of prognosis in heart failure patients and is associated with a higher presence of comorbidities that contribute to worse outcomes. However, fewer data are available for patients over 65 years of age, who are often excluded from major clinical and pharmacological trials.The FATE Study considers the population presenting the most common disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients.
The FATE Study considers the population presenting the most frequent disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients. With its specific characteristics, the Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.
- Conditions
- Heart Failure, Frailty
- Being tested
- usual care
- Keywords
- heart failure, Fraility, ELderly, primary and secondary prevention
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
The aim is to set up a collection of clinical and instrumental data of usual care from patients hospitalized for acute heart failure aged ≥ 65; at the time of admission and after 6-12 and 18 months from the event (admission).
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization or death at 12 months
Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.
Measured: up to 12 months
Secondary outcomes (3)
Hospitalization or death at 6-12-18 months
Prevalence of hospitalizations and/or death from all causes at 6, 12, and 18 months from enrollment;
Measured: up to 6-12-18 months
hospitalizations and/or death from cardiovascular causes
Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;
Measured: up to 6 and18 months
association between events and patient characteristics
Analysis of the association between events (hospitalization and/or death) and clinical characteristics, instrumental findings, and patient co-pathologies. Both cardiovascular events and those occurring for all causes will be evaluated, stratifying the analysis.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start19 Nov 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Multimedica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaia CAttadori, MD, Principal investigator, MultiMedica - IRCCS MultiMedica - Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343233
- Sponsor's protocol ID
- FATE
- Acronym
- FATE
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available.
PubMed 28455343Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
PubMed 23801822Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.
PubMed 29111106Krum H, Jelinek MV, Stewart S, Sindone A, Atherton JJ; National Heart Foundation of Australia; Cardiac Society of Australia and New Zealand. 2011 update to National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand Guidelines for the prevention, detection and management of chronic heart failure in Australia, 2006. Med J Aust. 2011 Apr 18;194(8):405-9. doi: 10.5694/j.1326-5377.2011.tb03031.x.
PubMed 21495941
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Observational Study of Patients Aged 65 Years or Older, Hospitalized for Acute Heart Failure.
- ClinicalTrials.gov ID
- NCT06343233
- Acronym / sponsor ID
- FATE / FATE
- Conditions
- Heart Failure, Frailty
- Keywords
- heart failure, Fraility, ELderly, primary and secondary prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- IRCCS MultimedicaUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- 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.
In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.
The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.
Detailed description
Heart failure is a clinical condition continuously growing, characterized by an unfavorable prognosis both in terms of life and health. It is increasingly common and often associated with other clinical conditions that complicate its course, worsen the prognosis, and increase costs for the National Health Service (NHS). Heart failure (HF) is characterized by high prevalence (3% of the adult population, approximately 600,000 patients already diagnosed in Italy) and incidence (0.1-0.2, 87,000 cases/year). Patients with chronic HF may experience disease exacerbations leading to frequent hospitalizations, which, however, are appropriate in only a minority of cases.
Heart failure is a leading cause of death and hospitalization, especially in patients over 65 years of age. The annual incidence of heart failure doubles for every decade over 65 years, with a prevalence reaching 10% in patients over 80 years of age. Age is also one of the major determinants of prognosis in heart failure patients and is associated with a higher presence of comorbidities that contribute to worse outcomes. However, fewer data are available for patients over 65 years of age, who are often excluded from major clinical and pharmacological trials.The FATE Study considers the population presenting the most common disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients.
The FATE Study considers the population presenting the most frequent disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients. With its specific characteristics, the Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older hospitalized for acute decompensated heart failure (ADHF). The index event must be documented, at the time of discharge, by the need for intravenous administration of specific treatments and classified based on the International Classification of Diseases (ICD-9 code 428 or codes consistent with the presence of any heart failure, for primary or secondary disease).
Key inclusion criteria (3 listed)
- Patients aged > 65 years;
- Patients hospitalized for acute heart failure;
- Signature of informed consent.
Key exclusion criteria (3 listed)
- Patients with significant valvular pathology at T0/Baseline (index event);
- Patients with malignant neoplasms or systemic pathology with a prognosis "quoad vitam" less than 1 year;
- Patients with known active infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual careThe aim is to set up a collection of clinical and instrumental data of usual care from patients hospitalized for acute heart failure aged ≥ 65; at the time of admission and after 6-12 and 18 months from the event (admission). | Other | – |
Primary outcome
Hospitalization or death at 12 months
Time frame: up to 12 months
Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.
3 secondary outcomes
Hospitalization or death at 6-12-18 months
Time frame: up to 6-12-18 months
hospitalizations and/or death from cardiovascular causes
Time frame: up to 6 and18 months
association between events and patient characteristics
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 28455343Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available.
- Results publication: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Results publication: PubMed 23801822Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.
- Results publication: PubMed 29111106Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.
- Results publication: PubMed 21495941Krum H, Jelinek MV, Stewart S, Sindone A, Atherton JJ; National Heart Foundation of Australia; Cardiac Society of Australia and New Zealand. 2011 update to National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand Guidelines for the prevention, detection and management of chronic heart failure in Australia, 2006. Med J Aust. 2011 Apr 18;194(8):405-9. doi: 10.5694/j.1326-5377.2011.tb03031.x.
- Individual participant dataSharing planned: Undecided
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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.
Gaia CAttadori, MD principal investigator
MultiMedica - IRCCS MultiMedica - Cardiology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Frailty, run by IRCCS Multimedica at 7 sites 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 3 inclusion and 3 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Gaia Cattadori, MD (+39 02 8687 8889, gaia.cattadori@multimedica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization or death at 12 months (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343233, which also lists 5 linked publications.
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 2 Apr 2024.