CardioNETPOL National Registry of Carcinoid Heart Disease

Sponsor
National Institute of Cardiology, Warsaw, Poland
Study ID
NCT07450287
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Observational Registry of Carcinoid Heart Disease — OTHER
    This study is a multicenter, retrospective, observational registry of patients with carcinoid heart disease. The "intervention" consists of systematic collection and analysis of clinical, echocardiographic, and laboratory data, including demographic characteristics, cardiovascular risk factors, tumor features, metastatic status, and prior or planned cardiac and oncologic treatments. Detailed echocardiographic assessment of valve structure and function, chamber dimensions, and ventricular performance will be performed. The registry also identifies patients potentially eligible for transcatheter valve interventions. No experimental treatment is administered; all patient management follows standard clinical practice.

Study Details

Carcinoid tumors are neuroendocrine tumors (NETs), most commonly originating from the gastrointestinal tract, that may secrete bioactive substances such as serotonin. Persistent exposure to these mediators can lead to carcinoid syndrome and, in up to 50% of patients, carcinoid heart disease (CHD). CHD is characterized by fibrotic degeneration of cardiac valves, predominantly right-sided, resulting in progressive valvular dysfunction and a significant increase in mortality. The mechanisms underlying selective cardiac involvement and predictors of disease progression remain incompletely understood. In addition, optimal timing and selection of surgical versus transcatheter valve interventions, particularly in high-risk patients, require further clarification. This multicenter, retrospective observational registry aims to identify and characterize patients with carcinoid heart disease and at least moderate valvular involvement. CHD is defined by confirmed neuroendocrine tumor, echocardiographic evidence of ≥ moderate valvular disease with features of fibrosis, elevated NT-proBNP (\>260 ng/L), and histopathological confirmation when available. Approximately 100-120 consecutive patients will be enrolled over 12 months. Standardized data collection will include detailed echocardiographic assessment, demographic and clinical characteristics, cardiovascular risk factors, comorbidities, tumor features, oncological treatment history, and cardiac management strategies. The primary objective is to describe the clinical profile and management of patients with CHD in a real-world multicenter setting. Secondary objectives include identifying factors associated with advanced valvular dysfunction and evaluating eligibility and outcomes of transcatheter valve therapies. The registry is expected to improve risk stratification and support clinical decision-making in carcinoid heart disease.

Key Dates

Start date
Jun 1, 2026
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
120 participants (estimated)

Primary Outcome Measure

Characterization of patients with carcinoid heart disease [ Time Frame: At baseline (time of registry enrollment or most recent echocardiogram) ]

Central Contacts

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