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Heart failure with preserved ejection fraction (HFpEF), perfusion and metabolism

Completed
Conditions
analysis of the disease
Heart failure
imaging
10019280
Registration Number
NL-OMON47584
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
48
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

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>-Impaired perfusion (assessed using CMR): myocardial perfusion reserve</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>-Impaired peripheral muscle metabolism (assessed using MR spectroscopy):<br /><br>PCr/ATP ratio<br /><br>-Endothelial dysfunction (1) glycocalyx thickness (2) Heat-induced hyperaemic<br /><br>response<br /><br>-Level of fibrosis: T1 mapping on CMR<br /><br>-Biomarkers of endothelial dysfunction, oxidative stress, fibrosis and<br /><br>inflammation</p><br>
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