Patient's Management Receiving Eplerenone Therapy (PERGAME)
2018年11月29日 更新者：Pfizer
Assessment Of Follow-Up Methods For Patients Treated In The Long-Term With A Specific Aldosterone Receptor Antagonist
On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are:
- To describe the characteristics of the population treated.
- To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations).
- To describe the follow-up methods of the treatment.
- To describe the possible interruptions of the treatment
調査の概要
詳細な説明
A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width.
In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%.
A sample size of N = 500 patients was therefore chosen.
研究の種類
観察的
入学 (実際)
160
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～95年 (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
The following patients may be selected to participate in the survey:
- Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
- Those likely to be followed by the same physician for a minimal period of twelve months.
説明
Inclusion Criteria:
The following patients may be selected to participate in the survey:
- Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date.
- Those likely to be followed by the same physician for a minimal period of twelve months.
Exclusion Criteria:
- Severe Kidney Disease
- Hyperkamiemia more than 5.5
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
- 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 |
|---|---|
|
Eplerenone
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this is an observational study non interventional
|
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 |
|---|---|---|
|
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
時間枠：Baseline
|
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction.
Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
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Baseline
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Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
時間枠：Baseline
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Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction.
Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
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Baseline
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Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
時間枠：Month 3
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Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
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Month 3
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Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
時間枠：Month 6
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Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
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Month 6
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Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
時間枠：Month 9
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Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
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Month 9
|
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Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
時間枠：Month 12
|
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
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Month 12
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
時間枠：Baseline, Month 3
|
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily).
A positive change indicated dosage increase and a negative change indicated dosage decrease.
|
Baseline, Month 3
|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
時間枠：Baseline, Month 6
|
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily).
A positive change indicated dosage increase and a negative change indicated dosage decrease.
|
Baseline, Month 6
|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
時間枠：Baseline, Month 9
|
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily).
A positive change indicated dosage increase and a negative change indicated dosage decrease.
|
Baseline, Month 9
|
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Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
時間枠：Baseline, Month 12
|
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily).
A positive change indicated dosage increase and a negative change indicated dosage decrease.
|
Baseline, Month 12
|
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Percentage of Participants Who Died in SAS Population
時間枠：Baseline up to Month 12
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Baseline up to Month 12
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|
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Percentage of Participants Hospitalized in FAS Population
時間枠：Baseline up to Month 12
|
Baseline up to Month 12
|
|
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Number of Participants With Worsened Renal Function
時間枠：Baseline up to Month 12
|
Baseline up to Month 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
時間枠：Baseline up to Month 12
|
Baseline up to Month 12
|
|
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Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
時間枠：Baseline up to Month 12
|
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
|
Baseline up to Month 12
|
|
Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
時間枠：Baseline up to Month 12
|
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
|
Baseline up to Month 12
|
|
Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
時間枠：Baseline up to Month 12
|
Baseline up to Month 12
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants With Other Notable Events in FAS Population
時間枠：Baseline up to Month 12
|
Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).
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Baseline up to Month 12
|
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Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
時間枠：Baseline up to Month 12
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Baseline up to Month 12
|
|
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Number of Measurements Per Month for Kalaemia Levels in FAS Population
時間枠：Months 3, 6, 9, 12
|
The presence of excess potassium in the circulating blood is called hyperkalaemia.
Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L).
Number of measurements per month for the kalaemia levels was reported.
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Months 3, 6, 9, 12
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Maximum Kalaemia Levels in Serum in FAS Population
時間枠：Baseline up to Month 12
|
The presence of excess potassium in the circulating blood is called hyperkalaemia.
Normal potassium serum level is 3.5 to- 5.0 mmol/L.
|
Baseline up to Month 12
|
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Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
時間枠：Baseline up to Month 12
|
The presence of excess potassium in the circulating blood is called hyperkalaemia.
Normal potassium serum level is 3.5 to- 5.0 mmol/L.
Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.
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Baseline up to Month 12
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Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
時間枠：Baseline, Months 3, 6, 9, 12
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New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest).
Percentage of participants in each functional class was reported.
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Baseline, Months 3, 6, 9, 12
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Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
時間枠：Baseline
|
Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.
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Baseline
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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
2008年9月1日
一次修了 (実際)
2010年12月1日
研究の完了 (実際)
2010年12月1日
試験登録日
最初に提出
2011年9月14日
QC基準を満たした最初の提出物
2011年9月22日
最初の投稿 (見積もり)
2011年9月26日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月19日
QC基準を満たした最後の更新が送信されました
2018年11月29日
最終確認日
2018年11月1日
詳しくは
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。