CardioNETPOL National Registry of Carcinoid Heart Disease

NCT07450287 | Not Yet Recruiting

• 1 other identifier: 1C.8/I/26
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoid Heart Disease; Neuroendocrine Tumors; Carcinoid Syndrome; Valvular Heart Disease Patients

Keywords

Carcinoid Heart Disease; Neuroendocrine Tumor; Carcinoid Syndrome; Valvular Heart Disease; Transcatheter Tricuspid Valve Intervention; Observational Study; Multicenter Registry; Right-Sided Heart Failure

Outcome Measures

Primary Outcomes (1)

• Characterization of patients with carcinoid heart disease

  Characterization of patients with carcinoid heart disease defined as: presence of neuroendocrine tumor with hepatic metastases, echocardiographic evidence of right-sided valvular disease (tricuspid and/or pulmonary valve involvement), and biochemical evidence of serotonin excess (elevated urinary 5-HIAA or serum serotonin)

  At baseline (time of registry enrollment or most recent echocardiogram)

Secondary Outcomes (3)

• Identification of patients eligible for transcatheter valve interventions

  Baseline

• Assessment of clinical factors associated with advanced valvular dysfunction

  Baseline

• Assessment of echocardiographic factors associated with advanced valvular dysfunction

  Baseline

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with carcinoid heart disease who are evaluated and treated at multiple tertiary cardiology and oncology centers across Poland, including the National Institute of Cardiology. Patients included in this registry represent a real-world, multicenter cohort of individuals with neuroendocrine tumors complicated by moderate to severe valvular heart disease. Data are collected retrospectively from consecutive patients meeting eligibility criteria, reflecting standard clinical practice and management of cardiac and oncologic care. The population includes both patients managed conservatively and those considered for surgical or transcatheter valve interventions.

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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

National Institute of Cardiology in Warsaw

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Carcinoid Heart Disease; Neuroendocrine Tumors; Serotonin Syndrome; Heart Valve Diseases; Heart Failure

Condition Hierarchy (Ancestors)

Malignant Carcinoid Syndrome; Carcinoid Tumor; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Heart Diseases; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Central Study Contacts

Piotr N Rudziński, MD, PhD

CONTACT

+48608499737; piotr.rudzinski@ikard.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: June 2026 - June 2027
• Access Criteria: Access to de-identified individual participant data (IPD) and supporting information (study protocol and statistical analysis plan) will be granted to qualified researchers upon reasonable request. Requests will be reviewed and approved by the registry steering committee and relevant local ethics boards. Approved researchers will have access to anonymized clinical, echocardiographic, laboratory, and treatment data through secure transfer or controlled access via the eCRF platform provided by the scientific platform of the Polish Cardiac Society. Data use will be governed by a data use agreement specifying conditions for confidentiality, publication, and compliance with applicable national and institutional regulations.

Locations

PL (1)