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Register:	ClinicalTrials.gov
Last refreshed on:	10 May 2021
Main ID:	NCT03863990
Date of registration:	19/02/2019
Prospective Registration:	Yes
Primary sponsor:	Bayer
Public title:	Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the Lungs START
Scientific title:	Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
Date of first enrolment:	July 15, 2019
Target sample size:	104
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03863990
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Argentina

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Consecutive newly diagnosed patients by Right heart catheterization (RHC) from
01-Jan-2012 to 31-Dec-2017, belonging to one of the following of Group 1 PAH
subgroups: Idiopathic (IPAH), or Heritable (HPAH), or Drug or toxin induced, or
Associated (APAH) with one of the following: Connective tissue disease; Congenital
heart disease with simple systemic to pulmonary shunt at least 1 year after surgical
repair; Portal Hypertension or HIV infection.

- Diagnosis of PAH by RHC exhibiting a mean pulmonary artery pressure (MPAP) = 25 mmHg
and a pulmonary artery wedge pressure (PAWP) =15 mmHg at normal or reduced cardiac
output, according to European Society of Cardiology and European Respiratory Society
(ESC/ERS) 2009 guidelines or MPAP = 25 mmHg and a PAWP =15 mmHg and a pulmonary
vascular resistance (PVR) > 3 WU according to ESC/ERS 2015 guidelines.

- Patients with at least one year documented follow up or that have died or received
transplant before 1 year of follow up after baseline RHC and that have initiated
treatment with a PAH-targeted medication.

Exclusion Criteria:

- Patients with severe concomitant left heart disease (left ventricular ejection
fraction <35%).

- Patients with restrictive lung disease (Forced vital capacity (FVC) <60% predicted)
other than connective tissue disease or obstructive lung disease (forced expiratory
volume (FEV) <60% predicted, with FEV1/FVC<70%).

- Clinical or radiological evidence of Pulmo-Veno-Occlusive Disease (PVOD) or Pulmonary
Capillary Haemangiomatosis (PCH).

- Hypertrophic obstructive cardiomyopathy.

- Severe proven or suspected coronary artery disease.

- Congenital or acquired valvular or myocardial disease if clinically significant apart
from tricuspid valvular insufficiency due to pulmonary hypertension.

- Underlying medical disorders at baseline with an anticipated life expectancy below 2
years (e.g. active cancer disease with localized and/or metastasized tumor mass) or
Clinical relevant hepatic dysfunction (Child-Pugh B and C) or Renal insufficiency
(glomerular filtration rate <30 mL/min).

- Diagnosis of a pulmonary hypertension from WHO groups 2, 3, 4 or 5.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: PAH medication

Primary Outcome(s)

Drug class of PAH-treatment after diagnosis [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Heart rate at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery pressure at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Cardiac Index (CI) at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Descriptive analysis of comorbidities at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

PAH risk status at baseline according to ESC/ERS 2015 guidelines [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

PAH-subgroup at baseline as assessed by physician [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery systolic pressure at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Overall survival rate [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary hypertension functional class according to WHO classification at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Body height at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary vasoreactivity at baseline by pulmonary artery pressure [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right atrial area at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Age at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

6-minute walking distance at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Time from diagnosis to death from any cause [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Peak oxygen consumption by cardiopulmonary exercise test at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Sex [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Syncope frequency at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Time from onset of diagnostic symptoms to PAH-diagnosis [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Body mass index at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Drug class of supportive PAH treatment [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Ethnicity [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Left ventricular ejection fraction at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right atrial pressure at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right ventricular function at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Concentration of diagnostic markers for heart failure in blood at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Systolic blood pressure at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Body weight at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pericardial effusion at baseline by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Symptoms progression at baseline assessed by physician [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Secondary Outcome(s)

Cause of death [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Concentration of diagnostic markers for heart failure in blood at follow-up [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Proportion of patients with intermediate+high PAH risk [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Proportion of patients with low PAH risk [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary hypertension functional class according to WHO classification at baseline [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Survival rate of patients with low risk for PAH [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Number of hospitalizations per year due to PAH-progression [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pericardial effusion at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right ventricular function at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary transplant [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

PAH risk status of patients without transplant being alive at the date of latest medical records according to ESC/ERS 2015 guidelines [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Peak oxygen consumption by cardiopulmonary exercise test at follow-up [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

6-minute walking distance at follow-up [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Pulmonary artery systolic pressure at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Syncope frequency at follow-up [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right atrial area at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Survival rate of patients with intermediate or high risk for PAH [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Time from diagnosis to death from any cause [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Symptoms progression at follow-up [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Left ventricular ejection fraction at follow-up by echocardiography [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

PAH risk status at follow-up according to ESC/ERS 2015 guidelines [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Right atrial pressure at follow-up by right heart catheterization hemodynamics [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Time from diagnosis to pulmonary transplant [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Time from diagnosis to first hospitalization due to PAH-progression [Time Frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018]

Secondary ID(s)

20267

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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