The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events
研究概览
简要总结
Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels may identify a patient at high risk for adverse outcome from their HF, even in periods of apparent stability.
It remains unclear, however, whether treating patients based on their NT-proBNP concentrations would be associated with better outcomes compared to standard HF therapy without measurement of NT-proBNP values.
The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to standard HF therapy without such 'hormone guided' treatment.
详细描述
300 patients with class II-IV heart failure (HF) due to systolic dysfunction (left ventricular ejection fraction <40%) and recent (within 6 months) destabilized HF will be randomized 1:1 to either 'standard of care' therapy for their HF versus 'standard of care plus NT-proBNP guided' care.
At randomization, patients at MGH will undergo a 2-dimensional echocardiogram for cardiac structure and function.
Patients randomized to the 'standard of care' arm of the study will receive aggressive therapy for their HF, including evidence-based addition/titration of therapeutic agents in the trial, such as carvedilol or metoprolol XL, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, spironolactone inhibitors (for those in class III or IV), digoxin (when applicable), loop diuretics, as well as nitrates with or without hydralazine. Biventricular pacing with/without ICD capability will be performed at the discretion of the investigator. Any changes in therapy will be accompanied by a 2 week follow up for re-assessment and further titration of medications, based on clinical judgment.
At each interim visit, patients in the 'standard of care' arm will have a Minnesota Living with Heart Failure questionnaire taken. For all visits, including those triggered by med changes, laboratories will be checked including serum chemistries; a sample of blood for blinded NT-proBNP, troponin T, and high sensitivity CRP will be obtained for measurement after the trial is complete.
Patients randomized to the 'standard of care plus NT-proBNP guided' arm will receive the same aggressive medical care as above, but will also have an unblinded measurement of NT-proBNP provided to the study investigator within an hour of first patient contact. Therapeutic decision-making will be first based on clinical acumen/judgment, but if the NT-proBNP is elevated, per protocol, the investigator will adjust therapies accordingly, including escalation of existing therapies with known effects on NT-proBNP levels, as well as possible addition of similar therapies not yet in use (such as spironolactone).
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years of age
- •Left ventricular ejection fraction ≤ 40%
- •NYHA class II-IV heart failure
- •Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
排除标准
- •Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
- •Inoperable aortic valvular heart disease
- •Life expectancy <1 year due to causes other than HF such as advanced cancer
- •Cardiac transplantation or revascularization indicated or expected within 6 months
- •Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1S <1 L when diagnosed as standard of care.
- •Subject unable or unwilling to provide written informed consent
- •Coronary revascularization (PCI or CABG) within the previous 3 months
研究组 & 干预措施
SOC
Standard of care HF therapy without NT-proBNP guidance
干预措施: Drug therapy for HF (Other)
NT-proBNP arm
NT-proBNP plus standard HF management
干预措施: NT-proBNP guided HF therapy (Other)
结局指标
主要结局
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events
时间窗: One year
次要结局
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of outpatient decompensated HF.(One year)
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on change in NT-proBNP levels, both the change in absolute value as well as in relative value, from baseline to end of study.(One year)
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on echocardiographic parameters including LV systolic and diastolic function, RV systolic and diastolic function, RV systolic pressures, degree of valvular(One year)
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of all cause mortality.(One year)
- Ability of cTnT and hsCRP, independently as well as together with NT-proBNP, to predict cardiovascular endpoints.(One year)
- Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on patient quality of life.(One year)
- Cost benefits of NT-proBNP guided HF therapy versus standard of care.(One year)
研究者
James L. Januzzi
Dr.
Massachusetts General Hospital