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临床试验/NCT03550235
NCT03550235Unknown不适用

Exploration of Dyspnea at Non-high BNP

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年10月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
4
主要终点
Occurence of HFpEF

研究概览

简要总结

Patients with unexplained stress dyspnea ( ≥ stage 2 NYHA), no significant underlying lung disease, with an ejection fraction > 50%, normal resting filling pressures, NTproBNP < 220 pg/ml in < 75 years, and < 450 pg/ml in ≥ 75 years will be studied with stress echocardiography and cardiometabolic stress test (VO2). These patients may have abnormal adaptation during exercise, suggesting that chronic symptoms may be related to a heart failure with preserved ejection fraction (HFPEF). More accurate and earlier diagnosis of HFPEF using stress echocardiography and VO2 may better manage stress dyspnea in patients and prevent progression of HFPEF.

A clinical assessment will be offered to people with unexplained stress dyspnea. The procedures and products used in this study are usually used as part of HFpEF's diagnostic strategy. During this assessment, carried out on an outpatient basis, an anamnesis collection, a cardiovascular clinical examination, an evaluation of dyspnea by the NYHA functional class and by 2 questionnaires, an electrocardiogram will be carried out, a 6-minute walk test, a biological blood test, a trans thoracic rest and stress cardiac ultrasound, respiratory functional tests (with diffusion capacity of lung for carbon monoxide (DLCO) and blood gas), and a metabolic stress test. A follow-up at 1 and 2 years is planned (visit, sampling and resting echocardiography).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 40 years of age, and under 80 years of age with unexplained effort dyspnea, able to pedal.
  • Echocardiographic ejection fraction > 50%
  • NTproBNP < 220 pg/ml in < 75 years, and < 450 pg/ml in ≥ 75 years

排除标准

  • Patient with coronary, valve, hypertrophic, hypertensive, infiltrative, constrictive, or rhythmic, significant and/or progressive heart disease.
  • BMI > 35 kg/m².
  • Unstable patient (systolic blood pressure < 90 mmHg, resting pulse > 100 BPM) or clinically congested (edema of the lower limbs, crackling in the lungs).
  • Patient with Pulmonary function testing (EFR) showing significant respiratory disease (FEV1/ vital capacity (CV) max < 0.7, total lung capacities (CPT)< LIN)
  • Chronic renal failure with creatinine clearance < 30 ml/min (MDRD) or dialysis
  • Patient with anemia (Hb < 12 g/dl)
  • Patient with hypo or hyperthyroidism on thyreostimulating hormone (TSH) value
  • Patient under justice safeguard measure or guardianship

结局指标

主要结局

Occurence of HFpEF

时间窗: during the 2 years of follow-up

HFpEF diagnosis will be made in attendance of following symptoms: * heart failure * NTproBNP\>125pg/ml * preservation of ejection fraction with Left Ventricular Ejection Fraction (LVEF)\>50% * structural heart disease with expansion of left ventricular mass (VM) (men: VM≥115 g/m² or women ≥ 95 g/m² and an E/e' ratio≥13

dyspnea on exertion

时间窗: during the 2 years of follow-up

NTproBNP levels at rest

时间窗: during the 2 years of follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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