Heart failure with preserved ejection fraction, early diagnosis

Completed

• Registration Number: NL-OMON29452
• Lead Sponsor: Academisch Ziekenhuis Maastricht (azM) Health Foundation Limburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Impaired perfusion (assessed using CMR): assess if myocardial perfusion is diminished in HFpEF compared to controls assessed by CMR.