Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A
Nesiritide
干预措施: Nesiritide (Drug)
B
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo.
时间窗: 24 hours
次要结局
- dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP(24 hours)
研究者
Henry Krum
Head Clinical Pharmacology
The Alfred