Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening cardiovascular disorder, characterised by marked symptomatic limitation and frequent hospitalization. It is particularly prevalent in older individuals (up to 10% of the population) and it has become the most common cause for hospitalization in people >65yrs. As such it is also one of the leading consumers of healthcare spending. Recurrent hospitalization is frequently due in significant part to the lack of viable therapeutic options for severe HF. During hospital admission, medications through a drip to give through a vein (intravenous therapy), is required to improve heart pumping capacity (such as milrinone).They are frequently used and in many cases prolonged treatment periods of intravenous therapy are required. In a growing number of cases, there is a need to continue this treatment at home, however this is particularly costly and often complicated by intravenous line infection. As such there is an expanding need for therapeutic options in patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid release form of oral milrinone were examined, however these studies demonstrated adverse effects due to its quick release.
This study aims to determine the safety and tolerability of slow release oral milrinone in advanced HF patients with no further clinical option and to evaluate its effects on HF status.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Victoria
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Melbourne、Victoria、オーストラリア、3004
- Alfred Hospital
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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
説明
Inclusion Criteria:
- Advanced HF (current inpatients) with no further clinical options as defined by treating cardiologist.
- NYHA III-IV
- LVEF<35%
- Recurrent hospitalization (>/=3 admissions in the preceding 12 months) for HF
- On optimal tolerated medical/device therapy. Stable therapy for 48hrs.
- Age 18-85 yrs
- Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
Exclusion Criteria:
- Hypotension (BPsys<85)
- Unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate >100).
- Severe renal impairment Cr>250umol/L or dialysis.
- Other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease.
- Pregnancy or female with childbearing potential and inability to use contraception
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
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:MIlrinone
ER milrinone
|
Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
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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 |
---|---|---|
Safety and tolerability
時間枠:3 months
|
Number of MACE events change from basline safety profile bloods (Full Blood Count, urea and creatine, Liver function counts) Change in haemodynamic measurements ECG and Blood pressure and HR Monitoring Swan Ganz insertion for haemodynamic measurements (RA volume , RVSP, CO, PA, PAWP)
|
3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
NYHA Class
時間枠:3 months
|
Change in Heart Failure Status
|
3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
6 minute walk test
時間枠:3 month
|
Change in exercise capacity
|
3 month
|
BNP
時間枠:3 month
|
3 month
|
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Number of Heart Failure Hospitalisation
時間枠:3 months
|
3 months
|
協力者と研究者
スポンサー
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 (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
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)