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NCT05114785Not yet recruiting

Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR

PReserved Ejection Fraction Evaluation and Recognition by Cardiac Magnetic Resonance

Source: ClinicalTrials.gov · Last updated 5 Jan 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
28 Sept 2021
Start date
Jan 2022
Primary completion date
Jan 2026
Lead sponsor
University of East Anglia
NCT number
NCT05114785

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From Jan 2022 to the primary completion date, Jan 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous medical history of EF \<50%

Other illness

  • Contraindication for invasive workup (allergy to contrast, severe renal insufficiency with estimated glomerular filtration rate (eGRF)\<30 ml/min).
  • Contraindications for a contrast-enhanced CMR study (allergy to contrast, incompatible devices or implants, severe claustrophobia).
  • Pregnancy
    • The extended observational arm of the study will have wider eligibility criteria
    • \- Patients undergoing cardiac MRI for clinical indications irrespective of EF

Other

  • Patients unable/unwilling to provide informed consent.
  • Bodyweight\>120 kg or inability to lie flat/still.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.