DECIPHER-HFpEF-DZHK12
Time period: 14.01.2018 - 31.01.2020
Status: Recruiting
EudraCT number: NCT03251183
Number of ehtics application: S-208/2018
Description of the study
Die „DECIPHER HFpEF“ Studie ist eine multizentrische Studie und wird durch das Institut für Experimentelle und Translationale Kardiovaskuläre Bildgebung der Goethe- Universität Frankfurt/Main (Goethe CVI) geleitet. Der Zweck dieser Studie ist es, die Bedeutung von Herz Magnetresonanztomographie (Herz-MRT)-Untersuchungen bei der Beurteilung von Patienten mit Herzversagen mit erhaltener Auswurffraktion (HFpEF) zu prüfen und die Rolle der nicht-invasiven bildgebenden Methoden (d.h. ohne körperlichen Eingriff) mit den routinemäßigen invasiven Untersuchungen der Hämodynamik (des Blutflusses mit körperlichem Eingriff) zu vergleichen.
Indication
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
Age-gender matched controls:
- 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
Healthy volunteers:
- 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
Criteria for exclusion
Main/reproducibility group:
- 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:
- 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:
- 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)
Grants
Die „DECIPHER HFpEF“ Studie wird mit Forschungsmitteln des Deutschen Zentrums für Herz und Kreislauf-Forschung (DZHK) unterstützt.
Persons
Contact
Dr. med. Manuela Licka