Status:
COMPLETED
Validation of CMR Against Invasive Haemodynamics in Patients With HFpEF
Lead Sponsor:
Goethe University
Collaborating Sponsors:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Conditions:
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
18+ years
Brief Summary
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). Onc...
Eligibility Criteria
Inclusion
- Main/reproducibility group:
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT03251183
Start Date
January 14 2018
End Date
December 31 2022
Last Update
March 10 2023
Active Locations (7)
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1
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany, 60590
2
Kerckhoff Klinik
Bad Nauheim, Germany
3
Charite Centrum Herz-, Kreislauf- und Gefäßmedizin
Berlin, Germany
4
University Hospital Göttingen
Göttingen, Germany