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Recruiting

NCT Number: NCT03845946

CLOUD-R HAE REGISTRY

Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.

Recruiting

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Key information

Conditions

Angioedema Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, Isere, 38043, France

Location status: Recruiting

Location contact

Laurence Bouillet, MD, PhD

CONTACT

[email protected]

+33476765565

About this study

The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.

The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.

The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.

Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".

Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.

Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient with isolated angioedema without associated wheals.
  • Patients with hereditary angioedema with or without C1 deficiency.
  • Major patient with consent (signature)
  • Minor patient whose parents / legal guardians have given their consent (signature)

Exclusion criteria

  • Patient unable to give consent.
  • Wheals with angioedema

Treatment and study plan

angioedema

Behavioral

electronic tracking book

Primary outcomes

  1. Demographic patient data

    Time frame: 5 years

    Sexe and age of patient

  2. Clinical characteristics

    Time frame: 5 years

    summary of patient visit report

  3. Comorbidity

    Time frame: 5 years

    additional diseases

  4. Angioedema diagnosis

    Time frame: 5 years

    type of angiodema

  5. Angioedema diagnosis

    Time frame: 5 years

    position of genetic mutation if applicable

  6. Angioedema diagnosis

    Time frame: 5 years

    biology marker : C1inh, C4, C1q, anti C1inh

  7. Angioedema diagnosis

    Time frame: 5 years

    family history

  8. Duration and severity of acute angioedema events

    Time frame: 5 years

    start date

  9. Duration and severity of acute angioedema events

    Time frame: 5 years

    localization

  10. Duration and severity of acute angioedema events

    Time frame: 5 years

    time before treatment

  11. Duration and severity of acute angioedema events

    Time frame: 5 years

    time to resolution

  12. Duration and severity of acute angioedema events

    Time frame: 5 years

    need access to hospital

  13. Treatments used in managing the acute angioedema event

    Time frame: 5 years

    name

  14. Treatments used in managing the acute angioedema event

    Time frame: 5 years

    dose

  15. Treatments used in managing the acute angioedema event

    Time frame: 5 years

    date and time of acute treatment

  16. Treatments used in the prophylaxis of angioedema

    Time frame: 5 years

    name

  17. Treatments used in the prophylaxis of angioedema

    Time frame: 5 years

    dose

  18. Treatments used in the prophylaxis of angioedema

    Time frame: 5 years

    start date

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Boccon-Gibod

CONTACT

[email protected]

+3347676767640

laurence bouilelt, MD, PhD

CONTACT

[email protected]

+33476765565

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

International Registry of Isolated Angioedema

Acronym: CloudRHAE

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2019
Registry last updated
Nov 1, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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