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3278

Registry of pulmonary arterial hypertension associated with connective tissue diseases (reconnective)
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05665556
Pulmonary Arterial Hypertension
Connective Tissue Disease
Source : Importé depuis le centre
Pulmonary Arterial Hypertension
Connective Tissue Diseases
Recrutement ouvert
Dernière modification : 2023/06/30
Médicament expérimental


Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Pulmonary Arterial Hypertension

Connective Tissue Diseases

Source : Importé depuis le centre

Profil des participants

Sexe(s) des participants

All

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

Incident and prevalent patients diagnosed with Group I associated with Connective Tissue Diseases (CTD)
Incident and prevalent patients diagnosed with Group IV Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) with evidence of a chronic thromboembolic pulmonary disease by ventilation/perfusion pulmonary gammagraph or computed tomography pulmonary angiogram with at least three months of total anticoagulation therapy.
Patient diagnosed with a connective tissue disease according to the classification criteria of the American College of Rheumatology.
Precapillary pulmonary hypertension confirmed by right heart catheterization (RHC): Mean pulmonary arterial pressure (mPAP) >20 mm Hg with a pulmonary arterial wedge pressure ≤ 15 mm Hg and Pulmonary vascular resistance (PVR) ≥ 2.0 Wood units

Exclusion Criteria:

Patients who meet the criteria for another group of pulmonary hypertension (Groups II, III or V).

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Pulmonary Arterial Hypertension (Group I) Donnée non disponible Group I Pulmonary Arterial Hypertension associated with Connective Tissue Diseases
  • Inconnu
  • Pulmonary Arterial Hypertension (Group IV) Donnée non disponible Group IV Pulmonary Arterial Hypertension associated with Connective Tissue Diseases
  • Inconnu
  • Pulmonary Arterial Hypertension (Group I)
    État du recrutement
    unknown
    Pulmonary Arterial Hypertension (Group IV)
    État du recrutement
    unknown
    Données à jour depuis : 30 juin 2023

    Description de l'étude

    Résumé de l'étude

    The RECONNECTIVE Registry is an observational single center study, focused on the subgroup of precapillary pulmonary hypertension related to connective tissue diseases. All patients will have hemodynamic confirmation by right heart catheterization and will be follow-up for at least 5 years from admission. All patients diagnosed with Group I Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) and Group IV Pulmonary Hypertension (PH) with CTD will be included. The purpose of the registry is to learn and understand the clinical outcomes and natural history of the pulmonary arterial hypertension in this subgroup of patients to improve the medical care and treatment.

    Source : Importé depuis le centre

    Connective tissue diseases represents an important risk factor for pulmonary hypertension, either due to vasculopathy or chronic pulmonary thromboembolism. These chronic conditions are characterized by being disabling, progressive and fatal in a short time and are caused by multiple mechanisms that results in remodeling of the pulmonary microvasculature and right heart failure.

    In recent years, due to international registries, we have acquired a better understanding of high-risk subpopulations, their poor prognostic factors, and the results of specific combination therapies. In Mexico, the National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) is a referral center for connective tissue diseases and pathologies of the pulmonary circulation. The RECONNECTIVE registry is a five years follow-up cohort that offers the possibility to obtain data regarding to the clinical characteristics and hemodynamic assesment of pulmonary circulation. The main objective is to evaluate the clinical course of the PAH in this subgroup of patients and their specific therapy for PAH.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 30 juin 2023
    Données à jour depuis : 30 juin
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05665556