Klinische Studien

DECIPHER-HFpEF-DZHK12


Laufzeit: 14.01.2018 - 31.01.2020
Status: Rekrutierend
EudraCT-Nummer: NCT03251183
Nummer Ethikantrag: S-208/2018

Beschreibung der Studie

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.

Indikation/Einschlusskriterien

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

Ausschlusskriterien

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)

 

 

Förderung

Die „DECIPHER HFpEF“ Studie wird mit Forschungsmitteln des Deutschen Zentrums für Herz und Kreislauf-Forschung (DZHK) unterstützt.

Personen

Portrait von Dr. med. Manuela Licka

Dr. med. Manuela Licka


Kontakt

Dr. med. Manuela Licka