Prospective Minnesota Study of ECHO Tissue Doppler Imaging in Cardiac Resynchronization Therapy
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Minnesota
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Coon Rapids、Minnesota、アメリカ、55433
- Metropolitan Cardiology Consultants
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Edina,、Minnesota、アメリカ、55417
- Minnesota Heart Clinic
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Minneapolis、Minnesota、アメリカ、55415
- Hennepin County Medical Center
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Minneapolis、Minnesota、アメリカ、55407
- Minneapolis Heart Institute
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St. Paul、Minnesota、アメリカ、55101
- Regions Hospital
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St. Paul、Minnesota、アメリカ、55102
- St. Paul Heart Clinic
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin
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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:
Moderate or severe heart failure defined as NYHA class III-IV despite optimal pharmacological heart failure therapy.
Stable Heart failure as defined as not hospitalized within the last month. A 12 lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate >50bpm, QRS duration >120ms and PR interval> 150ms Ejection Fraction <35% documented within the last 6 months by one of the following methods: echo ( standard or TEE) LV gram, or MUGA Clinically indicated to receive CRT Ability to complete all the study visits including geographic stability
Exclusion criteria:
Serum creatinine >3.5 Have or had a Myocardial infarct, unstable angina, percutaneous coronary intervention or coronary artery bypass graft during the preceding 30 days prior to enrollment.
Have had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
Dyspnea believed by the physician to be primarily related to lung disease. Have an atrial tachyarrhythmia that is permanent ( ie does not terminate spontaneously and cannot be terminated with medical intervention)or persistent (can be terminated with medical intervention but does not terminate spontaneously)within 90 days prior to enrollment Poor sinus node function that MD predicts will require >70% atrial pacing. Inability to perform the six minute walk. Life expectancy of less than 6 months due to other medical conditions or expected to undergo heart transplant within the next 6 months.
Have a mechanical tricuspid heart valve. Hypertrophic obstructive cardiomyopathy. Patients with a hypersensitivity to a 0.7mg nominal dose of dexamethasone. Surgically uncorrected primary valvular heart disease. Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
Patients who are younger than 18 years of age, pregnant, or who are mentally incompetent and cannot sign a patient informed consent.
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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
協力者と研究者
捜査官
- 主任研究者:Alan J Bank, MD、St. Paul Heart Clinic
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
心不全の臨床試験
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Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)