NL-OMON29452
Completed
Not Applicable
Heart failure with preserved ejection fraction (HFpEF), perfusion and metabolism
Academisch Ziekenhuis Maastricht (azM) Health Foundation Limburg0 sites72 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Ziekenhuis Maastricht (azM) Health Foundation Limburg
- Enrollment
- 72
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. All patients • Age \> 50 • Estimated glomerular filtration reserve (eGFR) \>30 ml/min • Body weight\<130kg 1\.1\. HFpEF group 1\.1\.1 All HFPEF patients •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\.1\.2 HFPEF with Diabetes Mellitus •Inclusion criteria as mentioned above and Diabetes Mellitus: oDiabetes Mellitus is diagnosed as history of diabetes and use of anti\-diabetic medication or fasting plasma glucose ≥ 7\.0 mmol/L or 2h\-post load glucose ≥ 11\.1 mmol/l. 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
Outcomes
Primary Outcomes
Not specified
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