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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)

2021年4月29日 更新者: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.

調査の概要

状態

完了

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

104

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Age at baseline
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

二次結果の測定

結果測定
メジャーの説明
時間枠
Pulmonary hypertension functional class according to WHO classification at baseline
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年7月15日

一次修了 (実際)

2020年5月11日

研究の完了 (実際)

2020年5月11日

試験登録日

最初に提出

2019年2月19日

QC基準を満たした最初の提出物

2019年3月4日

最初の投稿 (実際)

2019年3月5日

学習記録の更新

投稿された最後の更新 (実際)

2021年5月4日

QC基準を満たした最後の更新が送信されました

2021年4月29日

最終確認日

2021年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

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