NCT06517186招募中不适用
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction (MM-HFpEF) A HeartShare Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
研究概览
简要总结
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Definition of HFpEF: signs and/or symptoms of HF, NYHA functional class II-IV, and at least one of the following:
- Elevated BNP (≥75 pg/ml in sinus rhythm or ≥225 pg/ml in atrial fibrillation/flutter) or NTproBNP (≥225 pg/ml in sinus rhythm or ≥675 in atrial fibrillation/flutter) at baseline. Choice of BNP or NTproBNP is based on availability at each clinical center.
- Prior HF hospitalization (primary reason for the hospitalization is HF with elevated natriuretic peptide levels [using the thresholds listed above], requiring IV diuresis for HF, or pulmonary edema or pulmonary vascular congestion on chest radiography).
- Previously documented elevated pulmonary capillary wedge pressure (PCWP) at rest (≥15 mmHg) or during exercise (≥25 mmHg for supine exercise or PCWP/cardiac output ratio ≥2 mmHg/L/min for upright exercise).
- Elevated H2FPEF score69 (≥5) or HFA-PEFF70 score (≥5).
- Suspected HFpEF criteria
- Age ≥30 years.
- Left ventricular ejection fraction ≥50% measured by echocardiography, CMR or MUGA (measured within one year + clinical stability)
- Signs and/or symptoms of HF, NYHA functional class II-IV and all of the following:
- Does not meet BNP or NT-proBNP criteria for HFpEF (above)
- No prior HF hospitalization meeting HF criteria (above)
- No previous hemodynamic catheterization documentation of HF (as above)
排除标准
- 1. Inadequate echo or fluoroscopic images.
- Neck anatomy unfavorable for jugular venous cannulation
- Therapy with direct oral anticoagulants without cessation for a period (age, renal function, and agent specific) deemed adequate to normalize coagulation according to local clinical guidelines.
- Previous or ongoing therapy with warfarin with INR ≥ 1.6 measured day before or of EMB
- Platelet count < 50,000/ml
- Active bleeding or coagulation disorder
- Infection or fever
- Endocarditis
- Pregnancy
- Intracardiac thrombus
- RV Aneurysm
- Clinically significant tricuspid, pulmonary or aortic valve stenosis
- Tricuspid or pulmonary mechanical valve prosthesis
- Left bundle branch block
研究组 & 干预措施
HFpEF
Participants with HFpEF
Non-HFpEF
Participants without HFpEF
结局指标
主要结局
Number of participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
时间窗: Up to 5 years
次要结局
未报告次要终点
研究者
Sanjiv Shah
Stone Endowed Professor of Medicine, Director of Research, Bluhm Cardiovascular Institute, Principal Investigator, HeartShare Data Translation Center
研究点 (6)
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标识符
- NCT 编号
- NCT06517186
- 其他研究编号
- 24-000688
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否
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