<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02252705</url>
  </required_header>
  <id_info>
    <org_study_id>REMEHIP</org_study_id>
    <nct_id>NCT02252705</nct_id>
  </id_info>
  <brief_title>Mexican Registry of Pulmonary Hypertension</brief_title>
  <acronym>REMEHIP</acronym>
  <official_title>Mexican Registry of Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Remehip</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medicaweb, S.A.C.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Remehip</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective multicenter registry including incident patients and prevalent patients which&#xD;
      pretends to identify clinical characteristics, treatment trends in-hospital and four years&#xD;
      follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population&#xD;
      with well characterized Pulmonary Hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction. Pulmonary hypertension (PH) is a worldwide group of vascular diseases&#xD;
      characterized by progressive increase in pulmonary vascular resistance and pulmonary arterial&#xD;
      pressure with secondary vascular and right ventricular (RV) remodeling, RV dysfunction, heart&#xD;
      failure syndromes and, finally, premature death. In developed countries significant medical&#xD;
      advances have occurred in the last two decades including a more systematic assessment and&#xD;
      availability of new therapeutic approaches. In addition, current registries had shown new&#xD;
      data regarding epidemiology, demography, clinical presentation, treatment and prognosis.&#xD;
      However, the evidence coming from developing countries is scarce and more information is&#xD;
      necessary to identify current care in such populations. In the other hand, high quality&#xD;
      clinical registries may help to understand if the knowledge coming from clinical trials is&#xD;
      being properly applied and if their results are reproducible in day-to-day clinical practice.&#xD;
      The results of the REMEHIP, a registry with one-year enrollment and four-year follow-up will&#xD;
      hopefully broad the investigators knowledge about clinical profile, medical care, therapeutic&#xD;
      trends and outcome in a Mexican population with well characterized PH.&#xD;
&#xD;
      Variables to be included. In all patients: a) date of onset of symptoms, b) medical history,&#xD;
      c) personal and family history, c) treatment at enrollment, d) physical examination, d) WHO&#xD;
      function class, e) six-minute walk distance, f) ECG, g) chest x-ray, h) echocardiogram, i)&#xD;
      pulmonary function tests, j) V/Q lung scan and or pulmonary angiography, and/or pulmonary&#xD;
      angiotomography k) right heart catheterization, and whenever possible indicated acute&#xD;
      vasodilator challenge 11, 12, l) biomarkers: troponin I (TnI), brain natriuretic peptide&#xD;
      (BNP), D - dimer (DD), INR, n) current treatment, o) in-hospital and follow - up outcome, p)&#xD;
      MACE.&#xD;
&#xD;
      Visit office. Data will be collected in the first outcome and update through each follow-up&#xD;
      about expected PH symptoms, functional class (WHO), current treatment, dose, compliance,&#xD;
      collateral effects and concomitant medication, weight, blood pressure, heart and respiratory&#xD;
      rate, and biomarkers, when possible or feasible; in patients under oral anticoagulation INR&#xD;
      will be recorded in each visit.&#xD;
&#xD;
      Visits will be according with the standard health care of each center, but in general they&#xD;
      will be made at least one every six months.&#xD;
&#xD;
      Sites. In centers (outcome treatment and tertiary center), investigators with expertise and&#xD;
      experience in diagnosis, stratification and treatment of patients with PH will be involved.&#xD;
      Centers without expertise, but with facilities to diagnosis, stratification (six-minute walk&#xD;
      distance, pulmonary function tests, V/Q lung scan and or pulmonary angiography, right heart&#xD;
      catheterization, and biomarkers) will be included too, as long as they adhere to protocol.&#xD;
&#xD;
      Quality Criteria. Following criteria will be used to improve quality data: a) standardized&#xD;
      definitions, data and reports; b) tools for fast feedback; c) meetings among principal&#xD;
      investigators and steering committee, at least one per year; d) ethics procedures review; e)&#xD;
      electronic, simple and accessible data collection; f) rigorous center selection based on&#xD;
      investigators expertise and/or facilities resources); g) consecutive patients enrollment to&#xD;
      obtain representative sample; h) random centers audit; i) centralized data and statistical&#xD;
      analysis; j) report all data and consistent conclusion; and k) transparency of funds for any&#xD;
      publication. Furthermore, the quality of this registry will also be measured by the number of&#xD;
      publications and presentations in national and international meetings as has previously been&#xD;
      done.&#xD;
&#xD;
      Data collection. Electronic database will have 178 variables including among others, data of&#xD;
      onset symptoms, medical history, personal and family history, physical examination, six -&#xD;
      minute walk distance, treatment, ECG, chest x-ray, echocardiogram, pulmonary function tests,&#xD;
      V/Q lung scan, pulmonary angiography, right heart catheterization, acute vasodilator&#xD;
      challenge, biomarkers and (in the follow - up) MACE.&#xD;
&#xD;
      Statistics. Differences between continuous variables with normal distribution will be&#xD;
      examined by Student's t test. The test of Wilcoxon rank sum will be used when continuous&#xD;
      variables have failed in normality tests. To analyze categorical variables X2 will be used by&#xD;
      Fisher's exact test or Yates correction. A two-tailed test with a p value &lt; 0.05 will be&#xD;
      considered as statistically significant. Logistic regression analysis will be used to select&#xD;
      independent predictors in those variables that by univariate regression analysis had obtained&#xD;
      a p value &lt; 0.01. To avoid confusion, the relationship between historical variables for&#xD;
      atherosclerosis and cardiovascular events will be examined through logistic regression and&#xD;
      multivariate analysis. Cox proportional risk multivariate model will assess the relationship&#xD;
      between each of these variables. Kaplan-Meier survival curves and Cox proportional risk model&#xD;
      will be used for adjust survival analysis. A p value &lt; 0.05 will be considered as&#xD;
      statistically significant. Data will be expressed as percentages, mean, standard deviation,&#xD;
      odds ratio and CI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>4 years</time_frame>
    <description>In-hospital or outpatient heart failure, cardiogenic shock, syncope, cardiovascular death and bleeding complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>4 years</time_frame>
    <description>Secondary to right heart failure, cardiogenic shock, auricular or ventricular arrhythmia.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">875</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Incident patients</arm_group_label>
    <description>Patients with less than three months from diagnosis to start of the Registry or those who have been diagnosed during the recruitment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevalent patients</arm_group_label>
    <description>Patients who have been diagnosed with more than three months from diagnosis to start of the Registry.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Mexican patients older than 2 years with diagnosis of Pulmonary Hypertension from groups I&#xD;
        and IV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 2 years with: a) diagnosis of PH (PAH by RHC), b) Groups I and IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe pulmonary function abnormalities (vital capacity &lt; 60% predicted, FEV1 &lt; 50%&#xD;
             predicted)&#xD;
&#xD;
          -  Abnormal pulmonary capillary wedge pressure (&gt; 15 mmHg)&#xD;
&#xD;
          -  Refusal to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julio Sandoval, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Cardiologia</affiliation>
  </overall_official>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary arterial hypertension</keyword>
  <keyword>Mortality</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252705
org study id: REMEHIP
nct id: NCT02252705
lead sponsor: 
collaborator: 
has dmc: No
Prospective multicenter registry including incident patients and prevalent patients which
      pretends to identify clinical characteristics, treatment trends in-hospital and four years
      follow-up outcome through major adverse cardiovascular events (MACE) in a Mexican population
      with well characterized Pulmonary Hypertension.
Introduction. Pulmonary hypertension (PH) is a worldwide group of vascular diseases
      characterized by progressive increase in pulmonary vascular resistance and pulmonary arterial
      pressure with secondary vascular and right ventricular (RV) remodeling, RV dysfunction, heart
      failure syndromes and, finally, premature death. In developed countries significant medical
      advances have occurred in the last two decades including a more systematic assessment and
      availability of new therapeutic approaches. In addition, current registries had shown new
      data regarding epidemiology, demography, clinical presentation, treatment and prognosis.
      However, the evidence coming from developing countries is scarce and more information is
      necessary to identify current care in such populations. In the other hand, high quality
      clinical registries may help to understand if the knowledge coming from clinical trials is
      being properly applied and if their results are reproducible in day-to-day clinical practice.
      The results of the REMEHIP, a registry with one-year enrollment and four-year follow-up will
      hopefully broad the investigators knowledge about clinical profile, medical care, therapeutic
      trends and outcome in a Mexican population with well characterized PH.

      Variables to be included. In all patients: a) date of onset of symptoms, b) medical history,
      c) personal and family history, c) treatment at enrollment, d) physical examination, d) WHO
      function class, e) six-minute walk distance, f) ECG, g) chest x-ray, h) echocardiogram, i)
      pulmonary function tests, j) V/Q lung scan and or pulmonary angiography, and/or pulmonary
      angiotomography k) right heart catheterization, and whenever possible indicated acute
      vasodilator challenge 11, 12, l) biomarkers: troponin I (TnI), brain natriuretic peptide
      (BNP), D - dimer (DD), INR, n) current treatment, o) in-hospital and follow - up outcome, p)
      MACE.

      Visit office. Data will be collected in the first outcome and update through each follow-up
      about expected PH symptoms, functional class (WHO), current treatment, dose, compliance,
      collateral effects and concomitant medication, weight, blood pressure, heart and respiratory
      rate, and biomarkers, when possible or feasible; in patients under oral anticoagulation INR
      will be recorded in each visit.

      Visits will be according with the standard health care of each center, but in general they
      will be made at least one every six months.

      Sites. In centers (outcome treatment and tertiary center), investigators with expertise and
      experience in diagnosis, stratification and treatment of patients with PH will be involved.
      Centers without expertise, but with facilities to diagnosis, stratification (six-minute walk
      distance, pulmonary function tests, V/Q lung scan and or pulmonary angiography, right heart
      catheterization, and biomarkers) will be included too, as long as they adhere to protocol.

      Quality Criteria. Following criteria will be used to improve quality data: a) standardized
      definitions, data and reports; b) tools for fast feedback; c) meetings among principal
      investigators and steering committee, at least one per year; d) ethics procedures review; e)
      electronic, simple and accessible data collection; f) rigorous center selection based on
      investigators expertise and/or facilities resources); g) consecutive patients enrollment to
      obtain representative sample; h) random centers audit; i) centralized data and statistical
      analysis; j) report all data and consistent conclusion; and k) transparency of funds for any
      publication. Furthermore, the quality of this registry will also be measured by the number of
      publications and presentations in national and international meetings as has previously been
      done.

      Data collection. Electronic database will have 178 variables including among others, data of
      onset symptoms, medical history, personal and family history, physical examination, six -
      minute walk distance, treatment, ECG, chest x-ray, echocardiogram, pulmonary function tests,
      V/Q lung scan, pulmonary angiography, right heart catheterization, acute vasodilator
      challenge, biomarkers and (in the follow - up) MACE.

      Statistics. Differences between continuous variables with normal distribution will be
      examined by Student's t test. The test of Wilcoxon rank sum will be used when continuous
      variables have failed in normality tests. To analyze categorical variables X2 will be used by
      Fisher's exact test or Yates correction. A two-tailed test with a p value < 0.05 will be
      considered as statistically significant. Logistic regression analysis will be used to select
      independent predictors in those variables that by univariate regression analysis had obtained
      a p value < 0.01. To avoid confusion, the relationship between historical variables for
      atherosclerosis and cardiovascular events will be examined through logistic regression and
      multivariate analysis. Cox proportional risk multivariate model will assess the relationship
      between each of these variables. Kaplan-Meier survival curves and Cox proportional risk model
      will be used for adjust survival analysis. A p value < 0.05 will be considered as
      statistically significant. Data will be expressed as percentages, mean, standard deviation,
      odds ratio and CI.
observational model: Cohort
time perspective: Prospective
measure: Major adverse cardiovascular events
time frame: 4 years
description: In-hospital or outpatient heart failure, cardiogenic shock, syncope, cardiovascular death and bleeding complications.
measure: Cardiovascular death
time frame: 4 years
description: Secondary to right heart failure, cardiogenic shock, auricular or ventricular arrhythmia.
arm group label: Incident patients
description: Patients with less than three months from diagnosis to start of the Registry or those who have been diagnosed during the recruitment period.
arm group label: Prevalent patients
description: Patients who have been diagnosed with more than three months from diagnosis to start of the Registry.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 90 Years
healthy volunteers: No
last name: Julio Sandoval, MD
role: Principal Investigator
affiliation: Instituto Nacional de Cardiologia
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension