Efficacy of Pulmonary Pressure Guided Therapy in Stable Outpatients With Advanced Heart Failure - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
研究概览
简要总结
SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be invited to participate in this study. Included patients will be randomized in a 1:1 ratio to pharmacological HF treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system) or usual care consisting of pharmacological HF treatment.
Patients randomized into the CardioMEMS arm will be implanted within 30 (Cardiomems group only) days from randomization. After randomization, patients in both the CardioMEMS and the control arm will be seen at the outpatient clinic at Rigshospitalet after one and 6 months. At the final clinical follow-up visit at 6 months, participants will perform a 6 minute walk test (6MWT), cardiopulmonary exercise test (CPET), fill out a quality of life questionnaire (Kansas City Cardiomyopathy Questionnaire (KCCQ)) and blood samples will be drawn. Patients in the CardioMEMS arm will be managed according to previously published protocols for pulmonary artery pressure optimization (generally mean pulmonary pressure 10-25 mmHg) (Ref 1).
详细描述
Data recording:
Data will be recorded in an online database using an electronic case report form. The investigators will use limits for accepted input, when applicable, on variables to minimize errors and specify which units the observations should be registered in. The investigators will perform quality controls two to four times per year of the database where new entries will be checked for accuracy and completeness.
Statistical considerations:
Sample size:
SAINTS A More than 3000 patients are followed in the HF clinics on Zealand including the greater Copenhagen region. The investigators plan to include 400 patients in the primary outcome analysis (SAINTS A) and hypothesize that 20% will fulfill the modified criteria for advanced HF.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included in SAINTS A and fulfilling criteria for advanced HF (i.e., meeting primary endpoint for SAINTS A), although with a lower NT-proBNP cut-off level at ≥ 1000 pg/ml, but not referred for HTx or LVAD due to contraindications or patient preference
- •NYHA Functional class III
- •Be willing and able to upload pulmonary artery pressure information and comply with the follow-up requirements
排除标准
- •Systolic blood pressure < 90 mmHg
- •Chest circumference of > 165 cm if BMI is ≥35 kg/m2
- •Intolerance to all neurohormonal antagonists (i.e., intolerance to Angiotensin Converting Enzyme inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Angiotensin receptor II blocker - neprilysin inhibitor (ARNi), Mineralocorticoid Receptor Antagonists (MRA), hydralazine/isosorbide dinitrate, and betablockers)
- •Fluid overload with a maximum (or dose equivalent) diuretic intervention
- •Contraindications to 1-month dual antiplatelet therapy or anticoagulation therapy for post implantation
- •Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS pulmonary artery sensor
- •Implanted with mechanical right heart valve(s)
- •Pregnant or planning to become pregnant in the next 12 months
- •An active, ongoing infection
- •History of current or recurrent (≥2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thromboses
研究组 & 干预措施
CardioMEMS HF System group
Pharmacological heart failure treatment guided by an implanted wireless pulmonary artery hemodynamic monitor (CardioMEMS HF system)
干预措施: CardioMEMS HF System (Device)
Standard of care
Standard heart failure medical treatment
干预措施: Standard heart failure medical therapy (Drug)
结局指标
主要结局
Change in Quality of Life from baseline to 6 months follow-up measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
时间窗: 6 months from inclusion
The Kansas City Cardiomyopathy Questionnaire (KCCQ) score is a validated measure of quality of life in patients with HF. The range of the scale is 0-100, with higher values representing better quality of life.
次要结局
- Mean pulmonary artery pressure and diastolic pulmonary artery pressure(3 months from inclusion)
- Proportion reaching the preset pressure goal after 3 months(3 months from inclusion)
- Proportion reaching the preset pressure goal adjusted for baseline pulmonary artery pulsatility index(3 months from inclusion)
- Proportion of functioning devices(6 months)
- Proportion of patients improving > 5 points on KCCQ score(6 months)
- 6 minute walk test distance in meters(6 months)
- NTproBNP after 6 months(6 months)
- Estimated glomerular filtration rate (eGFR) in mL/min/1,73 m2(6 months)
- Time to hospitalization for heart failure(6 months)
- Days spent alive out of hospital(6 months)
- Mortality(6 months)
- Number of out-patients visits(6 months)
- Number of changes in loop diuretics and neurohomonal blockade(6 months)
- Peak oxygen uptake in ml/kg/min(6 months)
研究者
Finn Gustafsson
Sponsor-Investigator
Rigshospitalet, Denmark