NCT02252705

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
875

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

3.4 years

First QC Date

September 26, 2014

Last Update Submit

June 26, 2023

Conditions

Pulmonary Hypertension

Keywords

Pulmonary arterial hypertensionMortalitySurvival

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    In-hospital or outpatient heart failure, cardiogenic shock, syncope, cardiovascular death and bleeding complications.

    4 years

Secondary Outcomes (1)

  • Cardiovascular death

    4 years

Study Arms (2)

Incident patients

Patients with less than three months from diagnosis to start of the Registry or those who have been diagnosed during the recruitment period.

Prevalent patients

Patients who have been diagnosed with more than three months from diagnosis to start of the Registry.

Eligibility Criteria

Age2 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mexican patients older than 2 years with diagnosis of Pulmonary Hypertension from groups I and IV

You may qualify if:

  • Patients older than 2 years with: a) diagnosis of PH (PAH by RHC), b) Groups I and IV

You may not qualify if:

  • Severe pulmonary function abnormalities (vital capacity \< 60% predicted, FEV1 \< 50% predicted)
  • Abnormal pulmonary capillary wedge pressure (\> 15 mmHg)
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Julio Sandoval, MD

    Instituto Nacional de Cardiologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

June 28, 2023

Record last verified: 2023-06