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Phosphodiesterase-5 Inhibitor

Sildenafil 40mgx3 daily for Pulmonary Hypertension (SilHF-US Trial)

Phase 3
Waitlist Available
Led By Konstadina Darsaklis, MD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks and 24 weeks
Awards & highlights

SilHF-US Trial Summary

This protocol describes a 2-arm randomized 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 analyzed 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.

Eligible Conditions
  • Pulmonary Hypertension
  • Heart Failure

SilHF-US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Global Assessment (PGA)
Six minute walk test
Secondary outcome measures
1.Quality of Life (QoL) evaluation by EuroQol5D
Kansas City Cardiomyopathy Questionnaire (KCCQ)
New York Heart Association (NYHA) function class

SilHF-US Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Sildenafil 40mgx3 dailyActive Control1 Intervention
Sildenafil 40mgx3 daily for 6 months
Group II: Placebo tablet x3 dailyPlacebo Group1 Intervention
Placebo for Sildenafil 40mgx3 daily for 6 months

Find a Location

Who is running the clinical trial?

Helse Stavanger HFOTHER_GOV
191 Previous Clinical Trials
263,077 Total Patients Enrolled
Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,907 Total Patients Enrolled
Konstadina Darsaklis, MDPrincipal InvestigatorHartford Hospital

Frequently Asked Questions

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~3 spots leftby May 2025