CardioNETPOL National Registry of Carcinoid Heart Disease
Starting soon
Conditions studied: Carcinoid Heart Disease, Neuroendocrine Tumors, Carcinoid Syndrome, Valvular Heart Disease Patients
In brief
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 facts
- Study ID
- NCT07450287
- Run by
- National Institute of Cardiology, Warsaw, Poland
- People needed
- 120
- Starts
- 2026-06-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- Confirmed diagnosis of a neuroendocrine tumor consistent with carcinoid heart disease.
- Echocardiographic evidence of at least moderate valvular disease associated with endocardial fibrosis.
- Elevated NT-proBNP levels (>260 ng/L) consistent with cardiac dysfunction.
- Availability of relevant clinical, echocardiographic, and laboratory data.
- For patients who underwent cardiac surgery, histopathological confirmation of carcinoid-related cardiac tissue (if available).
- Ability to provide informed consent for participation in the registry (or waiver as per local ethics approval for retrospective data).
You may not qualify if…
- Patients with insufficient clinical or imaging data to confirm carcinoid heart disease.
- Presence of other primary cardiac conditions causing significant valvular disease unrelated to carcinoid syndrome (e.g., rheumatic heart disease, congenital valve disease)
- Active participation in interventional clinical trials that would conflict with registry data collection
- Patients younger than 18 years
Where it is running
- National Institute of Cardiology in Warsaw — Warsaw, Poland
Full record on ClinicalTrials.gov
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