Cardiac MRI in HF-PEF

• Research type

  Research Study

• Full title

  Effects of Aldosterone Antagonism in Heart Failure with Preserved Ejection Fraction (HF-PEF): Cardiac MRI, Echocardiography, Exercise Physiology & Quality of Life Assessment

• IRAS ID

  121727

• Contact name

  Sven Plein

• Contact email

  s.plein@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Eudract number

  2013-000867-10

• ISRCTN Number

  N/A

• Research summary

  Heart Failure with a Preserved Ejection Fraction (HF-PEF) affects approximately 30-50% of patients that carry a diagnosis of ‘Heart Failure’. Whereas in systolic dysfunction the abnormality is of LV contraction in HF-PEF the abnormality is of LV relaxation. There have been multiple large clinical trials that have demonstrated the efficacy of a range of pharmacological interventions in Heart Failure with Reduced Ejection Fraction (HF-REF), however there are no such trials in HF-PEF. Recent reports have suggested that the aldosterone antagonist Spironolactone may have beneficial effects on some aspects of cardiac function in HF-PEF, possibly linked to changes in tissue fibrosis.
  Cardiac Magnetic Resonance Imaging (CMR) is able to accurately define cardiac structure, function, LV mass and LV strain without the use of ionising radiation. Advanced MR techniques are also able to accurately characterise myocardial tissue and assess tissue fibrosis.
  This study aims to define mechanisms for effect of Aldosterone antagonism in the treatment of HF-PEF using CMR.
  Patients presenting with a diagnosis of HF-PEF will be randomised to no intervention or regular Spironolactone. A detailed cardiac MRI assessment will be performed at baseline in conjunction with echocardiography, excercise testing and a quality of life questionnaire. Following six months of treatment these tests will be repeated to determine if treatment is associated with change in tissue characteristics, cardiac relaxation or functional capacity.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0292

• Date of REC Opinion

  13 Nov 2013

• REC opinion

  Further Information Favourable Opinion