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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Chronic Disease Chronic Kidney Disease (CKD) Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antonella Valerio

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 disease

Time frame: 14 Months
IN-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:
- pairwise analyses
- hierarchical analyses
- 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

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Acronym: IN-CluDiMI

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 22, 2026
Registry last updated: Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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