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)
Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
調査の概要
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
入学 (実際)
連絡先と場所
研究場所
-
-
-
Multiple Locations、アルゼンチン
- Many facilities
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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
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
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20267
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?
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。