Pulmonary Arterial HypertensionRECONNECTIVENCT05665556
REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE)
An observational study of Pulmonary Arterial Hypertension and Connective Tissue Diseases, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, Connective Tissue Diseases
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteMexico
- Study dates
- 15 Dec 2022to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who meet the criteria for another group of pulmonary hypertension (Groups II, III or V).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
Jose Luis Hernandez Oropeza, PhD, 55 5487 0900 ext. 2209, elinternista@hotmail.com
Jose Luis Hernandez Oropeza, PhD
About this study
Official title: REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE) at the National Institute of Medical Sciences and Nutrition Salvador Zubirán
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.
Read the detailed description
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.
- Keywords
- Pulmonary Arterial Hypertension, Connective Tissue Disease
- Medical subject headings
- Pulmonary Arterial Hypertension, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
World Health Organization functional class (I-IV)
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)
Measured: 5 years
Assesment of the right ventricular function by echocardiogram (TAPSE, Right atrial area and pericardial effusion)
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)
Measured: 5 years
Concentration of serum brain natriuretic peptide
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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start15 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Hernandez Oropeza, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Jose Luis Hernandez Oropeza, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665556
- Sponsor's protocol ID
- 3278
- Acronym
- RECONNECTIVE
- Status last verified
- Jun 2023
- First submitted
- 19 Dec 2022
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE) at the National Institute of Medical Sciences and Nutrition Salvador Zubirán
- ClinicalTrials.gov ID
- NCT05665556
- Acronym / sponsor ID
- RECONNECTIVE / 3278
- Keywords
- Pulmonary Arterial Hypertension, Connective Tissue Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who meet the criteria for another group of pulmonary hypertension (Groups II, III or V).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
World Health Organization functional class (I-IV)
Time frame: 5 years
Assesment of the right ventricular function by echocardiogram (TAPSE, Right atrial area and pericardial effusion)
Time frame: 5 years
Concentration of serum brain natriuretic peptide
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Luis Hernandez Oropeza, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Connective Tissue Diseases, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Hernandez Oropeza, PhD (+52 55 5487 0900, elinternista@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.