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NCT07450287Not yet recruiting

CardioNETPOL National Registry of Carcinoid Heart Disease

Carcinoid Heart Disease National Registry of Poland

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
19 Feb 2026
Start date
1 Jun 2026
Primary completion date
1 Jun 2027
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
NCT number
NCT07450287

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 1 Jun 2026 to the primary completion date, 1 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Age

  • Patients younger than 18 years

Other

  • Active participation in interventional clinical trials that would conflict with registry data collection

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institute of Cardiology in Warsaw
Coordinator of this site? Confirm its status
WarsawPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.