Pulmonary Hypertension, Systolic Dysfunction
Conditions
Brief summary
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.
Interventions
DRUGSildenafil
Oral sildenafil 20 mg TID for 12 weeks
DRUGPlacebo
Oral placebo TID for 12 weeks
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of chronic heart failure (NYHA Class II and III) * LVEF ≤ 40% * Elevated systolic PAP: ≥ 40 mmHg * Patients must be treated with an ACE inhibitor, ARB, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1
Exclusion criteria
* Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms * Patients who have received Nitrates/NO donor or Cytochrome P450 3A4 inhibitors within 30 days prior to visit 1 * Patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1 * History of hypersensitivity or allergy to sildenafil or any excipients of its formulation * Patients with hypertension (sitSBP \>170 mmHg or sitDBP\>100 mmHg) or hypotension (sitSBP\<90 mmHg or sitDBP\<50 mmHg) * Patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation * Pregnant females or those of child bearing potential who have not had a negative pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 6-min-walk test distance | at 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic pulmonary arterial pressure (PAP) | at 6 weeks and 12 weeks |
| Change from baseline in [NT pro-BNP] | at 6 weeks and 12 weeks |
| Change from baseline in 6-min-walk test distance | at 6 weeks |
| Quality of life (QoL) assessed by EuroQoL(EQ-5D-3L) and EQ visual analogue scales (VAS) | at 6 weeks and 12 weeks |
| Delaying time to first occurrence of either cardiovascular events | 12 weeks |
| Improvement in NYHA functional class | at 6 weeks and 12 weeks |
Countries
South Korea
Contacts
Primary ContactBae
Outcome results
None listed