Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease (BNP in OAD)
Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure. As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition. The role of BNP in airways disease has never been studied although there is evidence to suggest that it will have a positive effect.
The current study is therefore a proof on concept study which will demonstrate whether BNP (nesiritide) will improve both heart failure and airflow obstruction in patient who have both.
The investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. Patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. They will receive a bolus of study medication followed by a 4 hour infusion. Before, at hourly intervals and immediately following the infusion the following data will be collected:
- dyspnoea score
- respiratory rate
- FEV1 (if able to be performed)
- peak respiratory flow rates (PEFR, if able to be performed)
- requirement for concomitant bronchodilator therapy
- urinary GMP At all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Victoria
-
Melbourne、Victoria、オーストラリア、3004
- Alfred Hospital
-
-
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:
- Males and females
- Over 18 years of age
- Confirmed written informed consent.
- Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition.
- Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.
COAD based on physician's assessment and requiring treatment as per standard emergency department protocols for this condition. Must have at least 2 of the following criteria:
- history of smoking > 20 pack years,
- prior history of PFTs within last 1 year consistent with COAD,
- history of chronic cough and sputum production,
- progressive dyspnea, episodes of acute bronchitis over at least 2 yrs
Exclusion Criteria:
- Women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods.
- Patients who had received an investigational new drug within the last 4 weeks.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- SBP <90mmHg
- Creatinine >0.25mmol/L
- Sp02 < 80% on supplemental oxygen or known cor pulmonale with TR
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:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
プラセボコンパレーター:B
プラセボ
|
プラセボ注入
|
実験的:A
Nesiritide
|
Nesiritide 4 hour infusion
|
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 |
時間枠 |
---|---|
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
時間枠:24 hours
|
24 hours
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP
時間枠:24 hours
|
24 hours
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Peter Cameron、Monash University / Alfred Hospital
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
-
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)
プラセボの臨床試験
-
Palacky University完了
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
-
Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
-
University Hospital, Strasbourg, France積極的、募集していない