The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
Oral sildenafil 20 mg TID for 12 weeks
Oral placebo TID for 12 weeks
11 institutions including Hallym University Dongtan Sacred Heart Hospital
Seoul, South Korea
RECRUITINGChange from baseline in 6-min-walk test distance
Time frame: at 12 weeks
Change from baseline in 6-min-walk test distance
Time frame: at 6 weeks
Change from baseline in systolic pulmonary arterial pressure (PAP)
Time frame: at 6 weeks and 12 weeks
Change from baseline in [NT pro-BNP]
Time frame: at 6 weeks and 12 weeks
Improvement in NYHA functional class
Time frame: at 6 weeks and 12 weeks
Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS)
Time frame: at 6 weeks and 12 weeks
Delaying time to first occurrence of either cardiovascular events
Time frame: 12 weeks
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