Clinical trial NCT05114785: Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR
Official title: PReserved Ejection Fraction Evaluation and Recognition by Cardiac Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Heart Diseases
Keywords: Heart failure
hemodynamics
magnetic resonance imaging
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
First posted: 2021-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Suspected heart failure patients
* Suspected coronary artery disease patients

Brief summary: Heart failure with preserved ejection fraction (HFpEF) is a common and growing condition with a poor prognosis but the pathophysiology and management are still being investigated. The PREFER-CMR project aims to evaluate and validate the application of novel 4D cardiac magnetic resonance flow dynamic methods to measure left ventricular pressures and validate these measurements with direct pressure measurement by coronary angiography. This is a prospective observational study of patients with HFpEF undergoing clinical evaluation with coronary angiography who will also undergo contemporaneous cardiac MRI. The primary outcome will be the level of agreement between the two methods using angiography as the reference method.

Detailed description: Heart failure with preserved ejection fraction (HFpEF) is prevalent, increasing in incidence and has a poor prognosis. Accurate left ventricular (LV) haemodynamic assessment is needed to diagnose and manage patients with HFpEF. The reference method for assessment is an invasive study using catheters to measure intra-ventricular pressure but this is rarely done due to its invasive nature, high procedural costs and lack of expertise, despite the fact that haemodynamic guided therapy is associated with reduced re-hospitalisation and mortality. Non-invasive methods of LV haemodynamic assessment are inaccurate. The Investigators have developed an accurate four-dimensional flow cardiac magnetic resonance (4D flow CMR) protocol which is non-invasive and addresses the issues with existing practices to evaluate HFpEF. This observational-analytical study aims to assess the utility of a non-invasive 4D flow CMR protocol for haemodynamic assessment of HFpEF, to generate clinical data to support future clinical trials, clinical translation and patient benefit. This research study will involve generating a precise haemodynamic model using invasive and non-invasive data of prospectively recruited patients. This model will be also optimised in clinical patients with arrhythmias. Also, observational data will be collected to test the model's prognostic value.

Eligibility criteria: Inclusion Criteria:

1. Adults: age≥18 years.
2. Typical HF symptoms (NYHA stage\>I) within the last six months.
3. Raised NTproBNP (\>400 pg/ml)
4. EF\>50 % with the absence of structural heart disease on TTE (except left ventricular hypertrophy or left atrial enlargement).

Exclusion Criteria:

1. Patients unable/unwilling to provide informed consent.
2. Bodyweight\>120 kg or inability to lie flat/still.
3. Contraindication for invasive workup (allergy to contrast, severe renal insufficiency with estimated glomerular filtration rate (eGRF)\<30 ml/min).
4. Contraindications for a contrast-enhanced CMR study (allergy to contrast, incompatible devices or implants, severe claustrophobia).
5. Previous medical history of EF \<50%
6. Pregnancy

The extended observational arm of the study will have wider eligibility criteria

- Patients undergoing cardiac MRI for clinical indications irrespective of EF

Primary outcomes:
measure: Left ventricular pressure measured by invasive angiography (reference method) and modelled by cardiovascular magnetic resonance imaging
timeFrame: 30 days
Secondary outcomes:
measure: Prognostic relevance of left ventricular pressures measured by cardiac MRI
timeFrame: Ten years
Other outcomes:
Locations:
Study officials:
affiliation: University of East Anglia
name: Pankaj Garg, MD
role: PRINCIPAL_INVESTIGATOR
References: