Sildenafil Versus Placebo in Chronic Heart Failure
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
This protocol describes a 2-arm randomised controlled pilot study assessing the tolerance,
safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will
be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and
III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension
(SPAP >40mmHg).
Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or
placebo therapy for 6 months in a 2:1 blinded fashion. 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 6-Minute Walk Test.
The study will also assess safety, tolerability, symptoms and quality of life.