Registry of Pulmonary Arterial Hypertension Linked to Connective Tissue Diseases
REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE) at the National Institute of Medical Sciences and Nutrition Salvador Zubirán
This study is collecting information from patients with pulmonary hypertension linked to connective tissue diseases to see how the condition progresses and improve treatment over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT05665556 on ClinicalTrials.gov |
What this trial studies
The RECONNECTIVE Registry is an observational study that focuses on patients with precapillary pulmonary hypertension associated with connective tissue diseases. It aims to gather data on clinical outcomes and the natural history of this condition over a five-year follow-up period. Patients will undergo hemodynamic confirmation through right heart catheterization to ensure accurate diagnosis and monitoring. The registry seeks to improve medical care and treatment strategies for this specific subgroup of patients.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with Group I or Group IV pulmonary arterial hypertension associated with connective tissue diseases.
Not a fit: Patients with pulmonary hypertension classified under Groups II, III, or V will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding and management of pulmonary arterial hypertension in patients with connective tissue diseases, leading to better treatment outcomes.
How similar studies have performed: Other international registries have shown success in understanding high-risk subpopulations and their treatment outcomes, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Mexico City
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Jose Luis Hernandez Oropeza, PhD — Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Study coordinator: Jose Luis Hernandez Oropeza, PhD
- Email: elinternista@hotmail.com
- Phone: +52 55 5487 0900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.