Validation of Cardiovascular Magnetic Resonance against Invasive Haemodynamics in Patients with Heart Failure with Preserved Ejection Fraction (Decipher HFpEF-DZHK12)

ID

NCT03251183

Status

Active

DZG

DZHK

Start date

01/14/2018

Parameters

Inclusion criteria
  • Main/reproducibility group: Inclusion Criteria: 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 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 year 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
  • Main/reproducibility group: Exclusion Criteria: 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: 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: 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)