CLOUD-R HAE REGISTRY

ConditionANGIOEDEMA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patient unable to give consent.

Wheals with angioedema

Trial population

Any patient with isolated angioedema without associated wheals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • angioedema

    Behavioral

    electronic tracking book

Treatment groups

1,000 Participants
are divided into 5 treatment groups
Group A: Hereditary angioedema type I/II1 intervention
Group B: Acquired angioedema1 intervention
Group C: Drug induced angioedema1 intervention
Group D: Mast cell induced angioedema1 intervention
Group E: Hereditary angioedema with nC1Inh1 intervention

Trial outcomes

Primary outcomes

1

Demographic patient data

Sexe and age of patient

Time frame
5 years
2

Clinical characteristics

summary of patient visit report

Time frame
5 years
3

Comorbidity

additional diseases

Time frame
5 years
4

Angioedema diagnosis

type of angiodema

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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