PMID- 23097067 OWN - NLM STAT- MEDLINE DCOM- 20130521 LR - 20151119 IS - 1879-0844 (Electronic) IS - 1388-9842 (Linking) VI - 15 IP - 1 DP - 2013 Jan TI - Sildenafil in Heart failure (SilHF). An investigator-initiated multinational randomized controlled clinical trial: rationale and design. PG - 119-22 LID - 10.1093/eurjhf/hfs152 [doi] AB - 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. FAU - Cooper, Trond J AU - Cooper TJ AD - Stavanger University Hospital, Stavanger, Norway. trond.cooper@gmail.com FAU - Guazzi, Marco AU - Guazzi M FAU - Al-Mohammad, Abdallah AU - Al-Mohammad A FAU - Amir, Offer AU - Amir O FAU - Bengal, Tuvia AU - Bengal T FAU - Cleland, John G AU - Cleland JG FAU - Dickstein, Kenneth AU - Dickstein K LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20121024 PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 RN - 0 (Phosphodiesterase 5 Inhibitors) RN - 0 (Piperazines) RN - 0 (Purines) RN - 0 (Sulfones) RN - BW9B0ZE037 (Sildenafil Citrate) SB - IM MH - Dose-Response Relationship, Drug MH - Exercise Tolerance/*drug effects MH - Female MH - Follow-Up Studies MH - Heart Failure/*drug therapy/physiopathology/psychology MH - Humans MH - Male MH - Phosphodiesterase 5 Inhibitors/administration & dosage MH - Piperazines/*administration & dosage MH - Purines/administration & dosage MH - *Quality of Life MH - Sildenafil Citrate MH - Stroke Volume/*drug effects MH - Sulfones/*administration & dosage MH - Surveys and Questionnaires MH - Treatment Outcome EDAT- 2012/10/26 06:00 MHDA- 2013/05/23 06:00 CRDT- 2012/10/26 06:00 PHST- 2012/10/26 06:00 [entrez] PHST- 2012/10/26 06:00 [pubmed] PHST- 2013/05/23 06:00 [medline] AID - hfs152 [pii] AID - 10.1093/eurjhf/hfs152 [doi] PST - ppublish SO - Eur J Heart Fail. 2013 Jan;15(1):119-22. doi: 10.1093/eurjhf/hfs152. Epub 2012 Oct 24.