The Effect of Vericiguat on Exercise Hemodynamics and Exercise Tolerance in Patients With Heart Failure and Reduced Ejection Fraction: The EVERHETT-HF Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in peak oxygen consumption (peak VO2) assessed by cardiopulmonary exercise testing
研究概览
简要总结
Heart failure with reduced ejection fraction (HFrEF) is associated with impaired exercise capacity and abnormal exercise hemodynamics despite contemporary guideline-directed medical therapy (GDMT). Vericiguat, a soluble guanylate cyclase stimulator, has demonstrated clinical benefits in selected patients with HFrEF, but its effects on exercise physiology remain incompletely understood.
The EVERHETT-HF study is a prospective observational cohort study designed to evaluate the effects of treatment with vericiguat on exercise capacity and invasive exercise hemodynamics in patients with stable HFrEF receiving maximally tolerated guideline-directed medical therapy (GDMT). Participants undergo comprehensive cardiopulmonary exercise testing (CPET) and exercise right heart catheterization (ERHC) to assess functional and hemodynamic responses during exercise.
详细描述
Patients with chronic heart failure with reduced ejection fraction (HFrEF) frequently demonstrate persistent impairment in exercise tolerance and abnormal exercise hemodynamics despite contemporary guideline-directed medical therapy (GDMT). Although vericiguat has demonstrated clinical benefits in selected HFrEF populations, the physiological effects of soluble guanylate cyclase stimulation on exercise performance and invasive exercise hemodynamics remain incompletely characterized.
The EVERHETT-HF study is a prospective observational cohort study designed to evaluate the association of vericiguat therapy with changes in exercise capacity and invasive exercise hemodynamics in patients with stable HFrEF receiving maximally tolerated GDMT. Treatment decisions, including the initiation and dose titration of vericiguat, are made according to routine clinical practice and the judgment of the treating physician, independent of the study protocol.
Consecutive eligible adult patients with chronic HFrEF are prospectively enrolled and categorized into two cohorts according to the treatment prescribed by their treating physician: patients receiving guideline-directed medical therapy (GDMT) alone and patients receiving GDMT plus vericiguat. Clinical management is not influenced by study participation.
All participants undergo comprehensive baseline evaluation, including clinical assessment, laboratory testing, cardiopulmonary exercise testing (CPET), and exercise right heart catheterization (ERHC). Follow-up assessments are performed after approximately 12 months using the same standardized evaluation protocol.
Cardiopulmonary exercise testing is performed on a cycle ergometer using a symptom-limited incremental exercise protocol. Functional parameters include peak oxygen uptake (peak VO₂), percentage of predicted peak VO₂, ventilatory efficiency (VE/VCO₂ slope), oxygen uptake efficiency slope (OUES), peak oxygen pulse, anaerobic threshold, respiratory exchange ratio (RER), and exercise duration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged ≥18 years. Chronic heart failure with reduced ejection fraction (LVEF ≤40%). Stable chronic heart failure receiving maximally tolerated guideline-directed medical therapy (GDMT).
- •Clinically stable for at least 6 months prior to enrollment without hospitalization for worsening heart failure or major modification of heart failure therapy.
- •Able to perform symptom-limited cardiopulmonary exercise testing (CPET). Eligible to undergo exercise right heart catheterization (ERHC). Able to provide written informed consent.
排除标准
- •Acute decompensated heart failure. Recent hospitalization for worsening heart failure (<6 months). Systolic blood pressure <110 mmHg. Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m². Severe hepatic dysfunction. Severe anemia (hemoglobin <9 g/dL). Contraindication to right heart catheterization. Inability to perform CPET. Pregnancy or breastfeeding. Any condition judged by the treating physician to preclude safe participation.
研究组 & 干预措施
Vericiguat + GDMT
Participants receiving oral vericiguat in addition to maximally tolerated guideline-directed medical therapy (GDMT) as part of routine clinical care. Treatment decisions were made by the treating physician independently of the study protocol.
干预措施: Vericiguat (Drug)
Vericiguat + GDMT
Participants receiving oral vericiguat in addition to maximally tolerated guideline-directed medical therapy (GDMT) as part of routine clinical care. Treatment decisions were made by the treating physician independently of the study protocol.
干预措施: Guideline-directed medical therapy (GDMT) for heart failure (Other)
GDMT Alone
Participants receiving maximally tolerated guideline-directed medical therapy (GDMT) without vericiguat as part of routine clinical care. Treatment decisions were made by the treating physician independently of the study protocol.
干预措施: Guideline-directed medical therapy (GDMT) for heart failure (Other)
结局指标
主要结局
Change in peak oxygen consumption (peak VO2) assessed by cardiopulmonary exercise testing
时间窗: Baseline to 12 months
Assessment of the change in peak oxygen consumption (peak VO₂) measured by cardiopulmonary exercise testing (CPET) between baseline and the 12-month follow-up.
Change in pulmonary capillary wedge pressure (PCWP)
时间窗: Baseline to 12 months
Assessment of the change in pulmonary capillary wedge pressure measured during exercise right heart catheterization between baseline and the 12-month follow-up.
次要结局
- Change in VE/VCO2 slope(Baseline to 12 months)
- Change in mean pulmonary artery pressure (mPAP)(Baseline to 12 months)
- Change in cardiac output(Baseline to 12 months)
- Change in cardiac index(Baseline to 12 months)
- Change in pulmonary vascular resistance (PVR)(Baseline to 12 months)
- Change in oxygen uptake efficiency slope (OUES)(Baseline to 12 months)
- Change in oxygen pulse(Baseline to 12 months)
- Change in anaerobic threshold(Baseline to 12 months)
研究者
Argyrios Ntalianis
Cardiologist Attending
Alexandra Hospital, Athens, Greece