Zürich Pulmonary Hypertension Outcome Assessment Cohort (ZHPHCohort)
調査の概要
状態
詳細な説明
PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.
Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Silvia Ulrich, MD
- 電話番号：++41442552220
- メール：pulmonalehypertonie@usz.ch
研究連絡先のバックアップ
- 名前：Isabel Schmied
- 電話番号：++41442552220
- メール：pulmonalehypertonie@usz.ch
研究場所
-
-
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Zurich、スイス、8091
- 募集
- University Hospital Zurich
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コンタクト：
- Silvia Ulrich, PD MD
- 電話番号：0041 44 255 22 20
- メール：silvia.ulrich@usz.ch
-
主任研究者：
- Silvia Ulrich, MD
-
-
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:
- Patients with precapillary pulmonary hypertension
- Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
- Written informed consent by the subject after information about the research project
Exclusion Criteria:
- Patients with severe concomitant left heart disease (left ventricular ejection fraction <40%).
- Patients with restrictive lung disease (FVC<60% predicted); obstructive lung disease (forced expiratory volume (FEV) <60% predicted, with FEV 1/FVC<70%).
- Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
PH target therapy
Patients receiving PH target therapy
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Patients receiving PH target therapy
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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 |
|---|---|---|
|
Survival
時間枠：10 years
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Transplant free survival will be registered
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10 years
|
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Change in the 6 minute walk distance
時間枠：10 years
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The change in 6 minute walk distance will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
New York Heart association (NYHA) functional class
時間枠：10 years
|
The change in NYHA class will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
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Score in health related Quality of Life (HRQoL) questionnaires
時間枠：10 years
|
The change in HRQoL class will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
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Hemodynamic parameters by echocardiography
時間枠：10 years
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The change in echo parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
|
Hospital days
時間枠：10 years
|
Days spent in the hospital
|
10 years
|
|
red- and white blood cell counts
時間枠：10 years
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The change in blood cell count will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
|
Partial pressures of oxygen and carbon dioxide, pH, bicarbonate, electrolytes
時間枠：10 years
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The change in arterial blood gas parameters taken from radial artery will be registered at 3, 6, 12 months and yearly thereafter, (ABL '90Flex'-blood gas analyzer, Radiometer, Switzerland)
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10 years
|
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Score on Short-Form-6 D, Euro-Qol 5 D (EQ-5 D), visual analogue scale, time trade-off, standard gamble test
時間枠：10 years
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The change in utility will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
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Overnight sleep study parameters
時間枠：10 years
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The change Overnight sleep study parameters will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
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Score in cognitive function tests
時間枠：10 years
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The change cognitive function will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
|
Cardiopulmonary exercise test parameters
時間枠：10 years
|
The change cardiopulmonary exercise test parameters will be registered at 3, 6, 12 months and yearly thereafter
|
10 years
|
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ECG parameters
時間枠：10 years
|
The change in ECG parameters will be registered at 3, 6, 12 months and yearly thereafter
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10 years
|
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Motion, step counts, metabolic equivalent
時間枠：10 years
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The change in Activity assessment parameters will be registered at 3, 6, 12 months and yearly thereafter with actigraphy
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10 years
|
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Level of tissue oxygenation and blood volume index of prefrontal and quadriceps muscle tissue
時間枠：10 years
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Changes in cerebral and muscle tissue oxygenation will be assessed after 3, 6, 12 months and yearly thereafter by Near-infrared-Spectroscopy
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10 years
|
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Time, maximal power in stair-ascent test
時間枠：10 years
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Changes in performance of stair ascent test will be assessed after 3, 6, 12 months and yearly thereafter
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10 years
|
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Performance in Sit to stand test
時間枠：10 years
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Changes in sit- to stand test will be assessed after 3, 6, 12 months and yearly thereafter
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10 years
|
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Level of C-reactive protein (CRP)
時間枠：10 years
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The change in CRP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by immunoassay ('Immulite 2000'; 'DPC'; Los Angeles; USA)
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10 years
|
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Level of N-terminal brain natriuretic peptide (BNP)
時間枠：10 years
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The change in BNP will be registered at 3, 6, 12 months and yearly thereafter, taken from venous blood sample, measured by Roche Modular Systems (Roche; Switzerland)
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10 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Silvia Ulrich, MD、University Hospital Zurich, Department of Pulmonology
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
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
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