2023-506634-70-00招募中4 期
Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in the mPAP/CO slope between randomization and 6 months thereafter
研究概览
简要总结
The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with HFpEF and secondary / atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho). Secondary endpoints include the changes in quantitative valve assessment (EROA), quality of life and different CPETecho parameters.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •(1) Age > 18 years (2) NYHA class II to IV (3) Written informed consent (4) Left ventricular ejection fraction ≥ 50% (5) Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures*, including raised natriuretic peptides** (6) ≥ moderate functional MR assessed by TTE within the previous year
排除标准
- •(1) Systolic blood pressure < 100 mmHg (2) Potassium ≥ 5.2 mmol/L (3) eGFR ≤ 25 ml/min/1.73m² (4) History of angioedema or unacceptable side effects during receipt of ACE inhibitors or ARBs (5) Structural mitral valve disease and previous or planned mitral valve intervention (6) Already receiving ARNI (sacubitril-valsartan) therapy (7) Severe comorbid condition limiting life expectancy < 24 months or inability to perform a maximal CPETecho
结局指标
主要结局
Change in the mPAP/CO slope between randomization and 6 months thereafter
Change in the mPAP/CO slope between randomization and 6 months thereafter
次要结局
- Changes in (1) Peak VO2 (2) Mitral effective regurgitant orifice area (EROA) (3) Natriuretic peptide levels (NTproBNP) (4) Left atrial volume (Left Atrial Volume Index, LAVI) (5) Left atrial function (Peak Atrial Longitudinal Strain, PALS) (6) VE/VCO2 slope (7) Patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)
研究者
Clinical Trial Unit
Scientific
Ziekenhuis Oost Limburg
研究点 (2)
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