Sildenafil in Heart Failure

• Research type

  Research Study

• Full title

  Sildenafil in Heart Failure (SilHF); An investigator initiated multi-national clinical research study.

• IRAS ID

  101701

• Contact name

  John Cleland

• Contact email

  j.g.cleland@hull.ac.uk

• Sponsor organisation

  Stavanger Health Research

• Eudract number

  2011-002829-21

• ISRCTN Number

  n/a

• Research summary

  Heart failure (HF) affects 2-3% of the adult population and the prevalence is increasing despite major advances in therapy over the last 20 years. The European Society of Cardiology estimates that 30 million patients have HF across Europe. This represents major burdens to patients and healthcare resources. HF is present in ~ 10% of hospital admissions and accounts for 2% of the national expenditure on healthcare across Europe, with some 50% of this expenditure being spent on hospitalisation. Morbidity is high amongst HF patients (50% within 4 years; 40% of patients admitted to hospital die or are re-hospitalised within 1 year).
  Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor which improves smooth muscle function and is commonly prescribed (as Viagra) to treat erectile dysfunction. However is mode of action is similarly relevant in the treatment of pulmonary hypertension (prescribed as Revatio, 20mg doses). Sildenafil has previously been assessed (50mg doses) in patients experiencing acute and chronic HF
  in short term studies, and there is evidence of significant use of off-label prescribing to symptomatic heart failure patients in most European countries.
  This is a 2-arm randomised controlled pilot study assessing the tolerance, safety and efficacy of sildenafil compared to control in patients with symptoms of chronic HF (NYHA class II or III), systolic dysfunction (EF <=40%) and secondary pulmonary hypertension (SPAP >40mmHg). Patients will be randomized to sildenafil (40mg x3) or placebo (matched tablets x3) in a 2:1 fashion for 6 months. The placebo group will be compared to the active therapy group and analysed for differences in the main study end-points Patient Global Assessment and exercise capacity (6 minute walk test). The main hypothesis is that sildenafil will be well tolerated and efficacious in this patients population. The study will also assess health economic benefits (QUALY), symptoms and biomarkers

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  13/YH/0346

• Date of REC Opinion

  23 Dec 2013

• REC opinion

  Further Information Favourable Opinion