NL-OMON47584CompletedNot Applicable
Heart failure with preserved ejection fraction (HFpEF), perfusion and metabolism - Heart failure with preserved ejection fraction, early diagnosis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 48
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. All patients
- •* Age > 50
- •* Estimated glomerular filtration reserve (eGFR) >30 ml/min
- •* Body weight<130kg ;1.1. HFpEF group
- •*Diagnosis of HFpEF, requires three conditions to be satisfied, as stated in the ESC guidelines:
- •(1) symptoms or signs of heart failure
- •(2) normal or only mildly reduced LV ejection fraction in a non-dilated LV (LVEF><= 50%)
- •(3) relevant structural heart disease (LV hypertrophy/LA enlargement) and/or diastolic dysfunction.
- •*Current BP < 160/90
- •*Estimated glomerular filtration reserve (eGFR) >30 ml/min
- •1.2 Hypertensive control patients;*No coronary artery disease (CAD; coronary stenosis>70% or history of CABG)
- •*No heart failure
- •*Estimated glomerular filtration rate (eGFR) > 30 ml/min
- •*Preserved left ventricular ejection fraction (LVEF) (><= 50%) on echocardiography
- •*No left ventricular hypertrophy (lateral and septal left ventricular wall <=<10mm)
- •*No left atrium enlargement
- •*No diastolic dysfunction type 2 or 3
- •*Blood pressure >140/90 mmHg or use of anti-hypertensive therapy
- •*Normal cardiac structure and function on echocardiography
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Age < 50 years
- •- Life expectancy of <1 year (malignancy etc.)
- •- Contraindication for CMR
- •* ODIN protocol:
- •* *Uitvoering van MRI onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD*
- •* ODIN protocol:
- •* *Voorbereiding klinische patiënten voor MRI onderzoek*
- •* Metallic implant (vascularclip, neuro-stimulator, cochlearimplant)
- •* Pacemaker or implantable cardiac defibrillator(ICD)
- •* Claustrophobia
- •* Persistent or chronic atrial fibrillation
- •- Contraindication to adenosine:
- •* High degree atrio-ventricular block (2nd or 3rd degree)
- •* Severe asthma bronchial
- •* Chronic obstructive pulmonary disease Gold * III
- •* Concomitant use of dipyridamole (Persantin)
- •* Long QT syndrome (congenital)
- •- Contraindication to gadolinium (Dihydroxy- hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol) - Gadovist ® )
- •* Severe renal impairment (Glomerular filtration rate (GFR) < 30 ml/min/1.73m2
Investigators
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