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Epidemiological Cluster Evaluation in Patients Admitted to Internal Medicine, With at Least One of the Following Diagnoses: Heart Failure, COPD, Renal Failure. The FADOI IN-CluDiMI Study

Epidemiological Cluster Evaluation in Patients Admitted to Internal Medicine, With at Least One of the Following Diagnoses: Heart Failure, COPD, Renal Failure. The FADOI IN-CluDiMI Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07660757
Acronym
IN-CluDiMI
Enrollment
4500
Registered
2026-06-22
Start date
2023-01-02
Completion date
2024-11-19
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease (CKD), Chronic Obstructive Pulmonary Disease (COPD), Heart Failure

Keywords

Internal Medicine, disease clusters

Brief summary

Improved medical care has led to an increase in both the age and clinical complexity of patients admitted to Internal Medicine wards, characterized by multiple chronic diseases. Multimorbidity is a common issue in the elderly, significantly associated with higher mortality, functional decline, and poorer quality of life. The concept of "disease clustering" goes beyond simple multimorbidity or comorbidity by grouping statistically associated morbid conditions to understand their interconnections, shared risk factors, and pathophysiological mechanisms. The goal is to identify these clusters in relation to the most common chronic conditions in Internal Medicine: heart failure, chronic obstructive pulmonary disease (COPD), and chronic kidney disease.This is an observational, multicenter, prospective, national study sponsored by the FADOI Foundation (Federation of Associations of Internal Medicine Hospital) and this is a non-profit research project. It aims to involve about 50 Internal Medicine Units, targeting the enrollment of approximately 100 consecutive adult patients per unit, for a total of at least 1500 subjects per pathology group.

Interventions

None listed

Sponsors

Fadoi Foundation, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients admitted to Internal Medicine with a diagnosis of at least one of the following chronic conditions: * heart failure * COPD * chronic kidney disease * Acceptance of participation in the study by signing the informed consent

Exclusion criteria

* Patients who do not consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Identifying disease clusters (defined as the co-presence of at least two additional diseases) in patients suffering from at least one of the following chronic diseases: heart failure, COPD, and chronic kidney disease14 MonthsIN-CluDiMI study primary objective was to map the structural patterns of disease clustering around HF, COPD, and CKD, and to evaluate their prevalence, functional impacts, and geographic distribution.We also investigated the prognostic role of these clusters on mortality (in-hospital and/or follow-up mortality). The analysis included all available comorbidities, excluding highly prevalent risk factors such as hypertension, diabetes mellitus and dyslipidaemia, which were analysed separately. The optimal number of clusters was determined using the silhouette index, selecting a solution that maximised cluster separation and internal cohesion. 3 complementary approaches were used to investigate co-occurrence patterns: 1. pairwise analyses 2. hierarchical analyses 3. a combinatorial analysis to identify the most prevalent triplets of co-occurring conditions within each disease-specific cohort This approach is considered the primary method for identifying recurrent multimorbidity patterns

Countries

Italy

Contacts

STUDY_CHAIROmbretta Para, PhD

Department of Medicine, AOU Careggi, Firenze

STUDY_DIRECTORFrancesco Dentali, Prof.

Department of Medicine, ASST-Settelaghi, Varese

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026