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Phosphodiesterase-5 Inhibitor

Sildenafil in US Heart Failure Patients (SilHF-US) (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
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions

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
  • Congestive Heart Failure
  • Pulmonary Hypertension
  • Heart Failure

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
199 Previous Clinical Trials
273,615 Total Patients Enrolled
Hartford HospitalLead Sponsor
139 Previous Clinical Trials
19,668 Total Patients Enrolled
Konstadina Darsaklis, MDPrincipal InvestigatorHartford Hospital
~3 spots leftby Dec 2025