NCT05665556 REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE)
| NCT ID | NCT05665556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 170 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 170 participants in total. It began in 2022-12-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Jose Luis Hernandez Oropeza, PhD
PRINCIPAL INVESTIGATOR
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Frequently Asked Questions
Who can join the NCT05665556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05665556 currently recruiting?
Yes, NCT05665556 is actively recruiting participants. Contact the research team at elinternista@hotmail.com for enrollment information.
Where is the NCT05665556 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT05665556 clinical trial?
NCT05665556 is sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The principal investigator is Jose Luis Hernandez Oropeza, PhD at Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The trial plans to enroll 170 participants.