Validation of Cardiovascular Magnetic Resonance Against Invasive Haemodynamics in Patients With Heart Failure With Preserved Ejection Fraction (DECIPHER HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 7
- 主要终点
- Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR).
研究概览
简要总结
Heart failure (HF) currently affects app. 2% of the western population and app. 10% of people >75 years. In about 50% of patients with symptomatic HF ejection fraction (EF) is preserved (HF-PEF). Once patients develop symptoms, the prognosis is poor with 25% mortality at 1 year and 50% mortality at 5 years. HFpEF is one of the major unresolved areas in clinical cardiology. The diagnosis of HFpEF remains a diagnosis of exclusion and currently no non-invasive measure provides a clear diagnosis.
Cardiovascular magnetic resonance (CMR) provides non invasive and radiation free evaluation of heart structure and function. New CMR parameters offer the possibility to describe the underlying pathological and physiological changes associated with HFpEF.
The investigators propose to undertake the first systematic comparison between a CMR protocol and invasive haemodynamics as the best possible gold standard, as well as define the histopathological drivers in myocardial biopsies. The investigators will also examine the relations with tissue and serological biomarkers implicated in HFpEF and the role with standard and novel parameters by echocardiography. If successful, this study will provide tools for a reliable and accurate non-invasive characterization of patients with HFpEF, supporting the diagnosis and grading the severity of disease. This study will provide a reference basis for future diagnostic algorithms in HFpEF, both, for CMR and echocardiography, but also for their relative value in comparison to blood markers or invasive testing. In addition to a new pathway to acess the effects of current and novel therapeutic interventions, the investigators see the greatest potential in identifying a disease stage where the myocardial injury may be reversible.
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
- 是
入选标准
- •Ability to provide informed consent
- •Typical HF symptoms (NYHA stage II-III) within the last 6 months
- •EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement)
- •Echocardiographic evidence of increased left ventricular filling pressures
- •E/E'sep >15 OR E/E'lat >12 OR Av E/E' >13 OR
- •E/E' >9 AND left atrial (LA) volume >34 ml/m2 OR systolic pulmonary artery pressure (PAsys): >35 mmHg;
- •Indication for invasive hemodynamic work-up
- •Unclear aetiology of heart failure
- •Adults: age >18 years
排除标准
- •Patients unable or unwilling to provide informed consent
- •High likelihood of non-diagnostic PV loops of MR imaging (e.g. atrial fibrillation or high rate of premature ventricular contraction (PVC) (> 10 ventricular Extrasystole (VES)/minute), > 150 kg body weight, inability to lie flat or still)
- •Contraindication for invasive work-up (allergy to contrast agent, severe renal insufficiency with estimated glomerular filtration rate (eGRF) <30 ml/min)
- •Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia)
- •Previous medical history of EF <45%
- •Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)
- •Age-gender matched controls:
- •Inclusion Criteria:
- •Ability to provide informed consent
- •No current or history of symptoms, signs or therapy for heart disease
- •EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement)
- •Adults: age >18 years
- •Exclusion Criteria:
- •Patients unable or unwilling to provide informed consent
- •High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)
- •Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia, severe renal insufficiency with eGRF <30 ml/min))
- •Previous medical history of EF <45%
- •Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)
- •Healthy volunteers:
- •Inclusion Criteria:
- •Ability to provide informed consent
- •No current or history of symptoms, signs or therapy for heart disease
- •EF ≥ 50 % with absence of structural heart disease on echocardiography
- •Exclusion Criteria:
- •Contraindications for an MR study
- •High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still)
- •Subjects unable or unwilling to provide informed consent
- •EF <50% in patient history
- •Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease)
结局指标
主要结局
Significant influence of MR Imaging Parameters on a multivariate model to describe the invasive pressure volume relations (EDPVR).
时间窗: up to 4 weeks. No follow up is planned.
Using a multivariable regression analysis and a respective F test.
次要结局
- Association between a model for diastolic function based on CMR with a model of diastolic function based on echocardiography(up to 4 weeks. No follow up is planned.)
- Association between CMR T1-mapping and biopsy results.(up to 4 weeks. No follow up is planned.)
- Association between CMR flow echocardiographic flow(up to 4 weeks. No follow up is planned.)
- Reproducibility at one site.(up to 4 weeks. No follow up is planned.)
- Variability between the different sites.(up to 4 weeks. No follow up is planned.)
- Association between CMR function and echocardiographic function(up to 4 weeks. No follow up is planned.)
- Discriminatory capacity of a multivariate model of invasive and a multivariate model of non-invasive variables.(up to 4 weeks. No follow up is planned.)
研究者
Prof. Eike Nagel
Univ. Prof. Dr. med.
Goethe University