Related Experiment Video
Updated: May 17, 2026
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Sildenafil in Heart failure (SilHF). An investigator-initiated multinational randomized controlled clinical trial:
Trond J Cooper1, Marco Guazzi, Abdallah Al-Mohammad
1Stavanger University Hospital, Stavanger, Norway. trond.cooper@gmail.com
Insights
Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, may improve exercise capacity and symptoms in heart failure (HF) patients with group 2 pulmonary hypertension (PH). This randomized trial will assess its efficacy and tolerability.
Area of Science:
- Cardiology
- Pulmonology
- Pharmacology
Background:
- Heart failure (HF) presents a significant clinical challenge with high mortality and reduced quality of life despite current therapies.
- Pulmonary hypertension (PH) in HF, particularly group 2 PH, is associated with poorer outcomes.
- Phosphodiesterase-5 (PDE-5) inhibitors have emerged as a potential therapeutic option for HF with group 2 PH.
Purpose of the Study:
- To evaluate the efficacy and tolerability of sildenafil, a PDE-5 inhibitor, in patients with HF and group 2 PH.
- To assess the impact of sildenafil on patient-reported outcomes and functional capacity.
Main Methods:
- The Sildenafil in Heart Failure (SilHF) trial is a randomized, placebo-controlled, multinational study.
- 210 patients with HF (NYHA class II-III) and group 2 PH will receive sildenafil (40 mg TID) or placebo.
- Co-primary endpoints include patient global assessment and the 6-minute walk test; secondary endpoints assess NYHA class and quality of life.
Main Results:
- This section is not yet available as the study is ongoing.
Conclusions:
- The study hypothesizes that PDE-5 inhibition with sildenafil can enhance exercise capacity and alleviate symptoms in patients with HF and group 2 PH.
- Acceptable tolerability of sildenafil is also anticipated in this patient population.
Aims:
Heart failure (HF) is a major clinical problem and, despite advances in both pharmacological and device therapy, the mortality remains high and quality of life poor. Over the last decade there has been growing interest in using phosphodiesterase-5 (PDE-5) inhibitors in HF associated with group 2 pulmonary hypertension (PH), with benefits reported on pulmonary haemodynamic and functional status in single-centre trials Methods The Sildenafil in Heart Failure (SilHF) trial is a randomized, placebo-controlled multinational trial designed to assess efficacy and tolerability of PDE-5 inhibition with sildenafil (target dose 40 mg three times per day) in 210 patients with HF, New York Heart Association (NYHA) functional class II or III, and evidence of group 2 PH. The co-primary endpoints are patient global assessment and the 6 min walk test. Secondary endpoints include NYHA functional class and the quality of life tools Euro QoL 5D and the Kansas City questionnaire. Patients will be followed up for 6 months.
Perspective:
The authors hypothesize that PDE-5 inhibition can improve exercise capacity and symptoms with acceptable tolerability in patients with HF and group 2 PH.
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