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NCT Number: NCT05665556

REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE)

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Connective Tissue Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location status: Recruiting

Location contact

Alice Yanine Ramirez Lozano, MD

SUB_INVESTIGATOR

Eduardo Rivero Sigarroa, MD

SUB_INVESTIGATOR

Jose Luis Hernandez Oropeza, PhD

CONTACT

[email protected]

55 5487 0900 ext. 2209

Jose Luis Hernandez Oropeza, PhD

PRINCIPAL_INVESTIGATOR

Jose de Jesus Rodriguez Andoney, M.Sc.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. To characterize the clinical clinical course of Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) in a register of Mexican patients from the first visit and at every 6 months.

    Time frame: 5 years

    Outcome measure: Clinical worsening: defined internationally by death, lung or heart-lung transplantation, atrial septostomy, hospitalization due to worsening PAH, initiation of new PAH approved therapy, or worsening WHO functional class.

Secondary outcomes

  1. World Health Organization functional class (I-IV)

    Time frame: 5 years

    Assesment of the functional class according to the World Health Organization (WHO) functional class (in scale from I-IV) in each scheduled visit (every 3 to 6 months) in the pulmonary hypertension clinic. It will help as part of the multiparametric variables to determine the comprehensive risk assessment (estimated 1-year mortality)

  2. Assesment of the right ventricular function by echocardiogram (TAPSE, Right atrial area and pericardial effusion)

    Time frame: 5 years

    Assesment of the right ventricular function by echocardiogram performed by an expert in echocardiography in each scheduled visit (every 6 to 12 months) in the pulmonary hypertension clinic. It will help as part of the multiparametric variables to determine the comprehensive risk assessment (estimated 1-year mortality)

  3. Concentration of serum brain natriuretic peptide

    Time frame: 5 years

    Concentration of serum brain natriuretic peptide in each scheduled visit (every 3 to 6 months) in the pulmonary hypertension clinic. It will help as part of the multiparametric variables to determine the comprehensive risk assessment (estimated 1-year mortality)

Study contacts

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

Jose Luis Hernandez Oropeza, PhD

CONTACT

[email protected]

+52 55 5487 0900

Jose de Jesus Rodriguez Andoney, M.Sc.

CONTACT

[email protected]

+52 55 5487 0900

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE) at the National Institute of Medical Sciences and Nutrition Salvador Zubirán

Acronym: RECONNECTIVE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2022
Registry last updated
Jun 29, 2023

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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