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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)

2021년 4월 29일 업데이트: Bayer

Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)

In this study researchers want to learn more about Pulmonary Arterial Hypertension, a type of high blood pressure in the lungs related to the narrowing of the small blood vessels in the lungs (group 1 according to WHO classification). Goal of the study is to describe the signs and risk factors of the illness at study start and the chances of survival.

연구 개요

상태

완전한

상세 설명

The primary objective of the study is to describe baseline clinical characteristics and overall survival in a cohort of patients with pulmonary arterial hypertension (PAH) of WHO functional class I in Argentina.

Secondary objectives are to study the discriminatory ability of the risk assessment tool presented in the European Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines and to explore the potential prognostic advantage of a low-risk profile at follow-up as treatment goal.

연구 유형

관찰

등록 (실제)

104

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Adults patients with pulmonary arterial hypertension from tertiary care centers in Argentina

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Patients with PAH
Adult male and female patients from Argentina diagnosed with pulmonary arterial hypertension (PAH) of WHO functional class I between 01-Jan-2012 and 31-Dec-2017 and with at least one year of follow-up.
Any PAH-targeted medication

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Age at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Sex
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Ethnicity
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Descriptive analysis of comorbidities at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-subgroup at baseline as assessed by physician
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-subgroups may be idiopathic, heritable, drug- or toxin-induced, or associated PAH (with CTD or HIV or portopulmonary hypertension or repaired congenital heart disease).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial pressure at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vasoreactivity at baseline by pulmonary artery pressure
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Yes / No - variable
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have no, mild, moderate or severe pericardial effusion.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have a normal, mild, moderate and severe right ventricular function.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at baseline by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary hypertension functional class according to WHO classification at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from onset of diagnostic symptoms to PAH-diagnosis
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at baseline assessed by physician
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patient may display no, a slow or rapid progression of symptoms.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
No, occasional or repeated syncope
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Systolic blood pressure at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Heart rate at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body weight at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body height at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body mass index at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Drug class of supportive PAH treatment
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Drug class of PAH-treatment after diagnosis
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-treatments are assigned to six drug classes: endothelin receptor antagonists (ERA), PDE5 inhibitors, prostanoides, prostacyclin receptor agonists, soluble guanylate cyclase (sGC) stimulants and calcium blockers.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at baseline according to ESC/ERS 2015 guidelines
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Overall survival rate
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

2차 결과 측정

결과 측정
측정값 설명
기간
Pulmonary hypertension functional class according to WHO classification at baseline
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial pressure at follow-up by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at follow-up
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at follow-up by echocardiography
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at follow-up
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at follow-up
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at follow-up
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at follow-up
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at follow-up according to ESC/ERS 2015 guidelines
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cause of death
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary transplant
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Yes or No
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to pulmonary transplant
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to first hospitalization due to PAH-progression
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Number of hospitalizations per year due to PAH-progression
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with low PAH risk
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with intermediate+high PAH risk
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with low risk for PAH
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with intermediate or high risk for PAH
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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
기간: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 7월 15일

기본 완료 (실제)

2020년 5월 11일

연구 완료 (실제)

2020년 5월 11일

연구 등록 날짜

최초 제출

2019년 2월 19일

QC 기준을 충족하는 최초 제출

2019년 3월 4일

처음 게시됨 (실제)

2019년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 5월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 4월 29일

마지막으로 확인됨

2021년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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