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

NCT05665556 | Recruiting

• 1 other identifier: 3278
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension; Connective Tissue Diseases

Keywords

Pulmonary Arterial Hypertension; Connective Tissue Disease

Outcome Measures

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.

  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.

  5 years

Secondary Outcomes (3)

• World Health Organization functional class (I-IV)

  5 years

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

  5 years

• Concentration of serum brain natriuretic peptide

  5 years

Study Arms (2)

Pulmonary Arterial Hypertension (Group I)

Group I Pulmonary Arterial Hypertension associated with Connective Tissue Diseases

Pulmonary Arterial Hypertension (Group IV)

Group IV Pulmonary Arterial Hypertension associated with Connective Tissue Diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Group I Pulmonary Arterial Hypertension (PAH) associated to Connective Tissue Diseases (CTD) and Group IV Pulmonary Hypertension group (PH) with CTD.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Luis Hernandez Oropeza, PhD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Luis Hernandez Oropeza, PhD

CONTACT

+52 55 5487 0900; elinternista@hotmail.com

Jose de Jesus Rodriguez Andoney, M.Sc.

CONTACT

+52 55 5487 0900; andoneyjjr@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Pulmonary Hypertension Clinic

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 27, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)