Sildenafil in US Heart Failure Patients (SilHF-US)
SilHF-US
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 heart-failure
Started Feb 2018
Shorter than P25 for phase_3 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2018
CompletedFirst Submitted
Initial submission to the registry
March 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 9, 2018
March 1, 2018
10 months
March 4, 2018
March 4, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Six minute walk test
Analysis of change from the baseline
Baseline, 8 weeks and 24 weeks
Patient Global Assessment (PGA)
Analysis of change form the baseline
Baseline; 8 weeks and 24 weeks
Secondary Outcomes (3)
1.Quality of Life (QoL) evaluation by EuroQol5D
Baseline, 8 weeks and 24 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Baseline, 8 weeks and 24 weeks
New York Heart Association (NYHA) function class
Baseline, 8 weeks and 24 weeks
Study Arms (2)
Sildenafil 40mgx3 daily
ACTIVE COMPARATORSildenafil 40mgx3 daily for 6 months
Placebo tablet x3 daily
PLACEBO COMPARATORPlacebo for Sildenafil 40mgx3 daily for 6 months
Interventions
Eligibility Criteria
You may qualify if:
- Men and women
- years of age.
- Outpatients with chronic HF. NYHA class II-III on optimal treatment in sinus rhythm or atrial fibrillation
- LVEF ≤ 40% measured during the past 12 months
- SPAP ≥ 40mmHg using echocardiography
- MWTD \< 475 meters
- NT-pro BNP ≥ 400 pg/ml or BNP ≥100 pg/ml, measured during the past 12 months
You may not qualify if:
- Acute Coronary Syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months
- Stroke within the last 3 months
- Planned coronary angiography or planned device-implantation
- Moderate to severe obstructive valve disease
- Documented episodes of sustained ventricular tachycardia
- Prior (past 30 days before the baseline visit) or ongoing use of oral nitrate therapy.
- Concomitant disease which interfere with assessment of dyspnea , severe COPD, asthma, restrictive lung disease, severe obesity
- Anemia (hemoglobin \< 10g/dL)
- Uncontrolled hypertension ( SBP \>160 mmHg and / or DBP \> 90 mmHg)
- Symptomatic or orthostatic hypotension or systolic blood pressure \< 90 mmHg
- Clinically important renal dysfunction (GFR \< 40m ml/min)
- Women with child-bearing potential
- Prior (past 30 days before the baseline visit) or ongoing use of i) alpha-1 antagonist: doxazosin ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itrakonazole, ketokonazole iii) CYP3A4-inducers: rifampicin iv) Any calcium channel blockers
- V) Pulmonary vasodilators at the treatment dose level for Pulmonary hypertensionRetinitis pigmentosa, previous diagnosis of NAION (non-arteritic ischemic opticus-neuropathy), unexplained visual disturbance.
- Sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, Peyronie's disease) that increases the risk of priapism.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hartford Hospitallead
- Helse Stavanger HFcollaborator
Study Sites (1)
Hartford Hospital 80 Seymour street
Hartford, Connecticut, 06102, United States
Related Publications (2)
Guazzi M, Dickstein K, Vicenzi M, Arena R. Six-minute walk test and cardiopulmonary exercise testing in patients with chronic heart failure: a comparative analysis on clinical and prognostic insights. Circ Heart Fail. 2009 Nov;2(6):549-55. doi: 10.1161/CIRCHEARTFAILURE.109.881326. Epub 2009 Sep 28.
PMID: 19919979RESULTCooper TJ, Guazzi M, Al-Mohammad A, Amir O, Bengal T, Cleland JG, Dickstein K. Sildenafil in Heart failure (SilHF). An investigator-initiated multinational randomized controlled clinical trial: rationale and design. Eur J Heart Fail. 2013 Jan;15(1):119-22. doi: 10.1093/eurjhf/hfs152. Epub 2012 Oct 24.
PMID: 23097067RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konstadina Darsaklis, MD
Hartford Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 4, 2018
First Posted
March 9, 2018
Study Start
February 14, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 9, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- The only US site at Hartford Hospital will complete enrollment by the end of year 2018. Data will be available and study database will be updated within 5 days of any obtained f-u visit.
- Access Criteria
- De-identified coded data will be entered into a secure login study database.
The SilHF trial is an international, multi-centre effort with five participating European centres.The Steering Committee of the SilHF trial, has elected to pool the individual patient data from the five European centers with a large single center in Hartford Connecticut, USA, PI: Konstadina Darsaklis. The US site will follow an identical protocol to the European sites and enter data on the electronic case report form to the data management centre in Trondheim, Norway. We intend to perform the meta-analysis independent of the results of the separate studies. All sites have obtained the required regulatory approvals.