A Phase 3 interventional study of Sildenafil and Placebo oral capsule in Heart Failure and Pulmonary Hypertension, sponsored by Hartford Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by Hartford Hospital · Phase 3, Interventional, and Treatment
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.
It is estimated that 2-3 % of the adult population suffers from heart failure (HF) and the prevalence is increasing. The European Society of Cardiology (ESC) represents countries with a population > 1,1 billion, and it is estimated that approximately 30 million patients have HF in these 53 countries. Heart failure is particularly prevalent in the elderly population and represents a major burden for both patients and the health services. In United states (US) more than 5 million people, or almost 2% of population have HF (Go at al, 2013) Medicare data indicate that 12% to 27% of patients hospitalized for heart failure are readmitted within 30 days after their discharge, and all-cause mortality reaches 12% in the same period. (Jencks at al, 2009).
Despite optimal non-pharmacological, pharmacological and device therapy, the morbidity among HF patients is high with symptoms such as dyspnoea and fatigue that reduce quality of life. Following diagnosis approximately 50% are dead after 4 years. Forty percent of patients admitted to hospital with HF are either dead or hospitalized within one year.
During the last decade, PDE5-inhibitors have been evaluated as a potential treatment for heart failure (see scientific rationale and reference). However, these investigations have been small and there is still limited data. Trials assessing the acute effects of PDE5-inhibition in patients with symptomatic HF due to systolic dysfunction have been performed primarily with sildenafil. Due to the short half-life of sildenafil the drug is administered 3 times daily when studying its chronic effects.
Previous studies have evaluated the 50 mg dose acutely and 50 mg 3 times daily during short-term chronic studies. Importantly, there is considerable off-label use of sildenafil in symptomatic heart failure patients in most European countries.
Revatio is currently licensed for pulmonary hypertension group 1. The dosing scheme is 20mg x 3. However, we suggest targeting a higher dose to achieve optimal clinical benefit in patients with heart failure and moderate congestion. As mentioned above most of the clinical literature in patients with symptomatic heart failure has been done using the 50mg x 3 regimen. However, it is believed that in the proposed study using 40mg x 3 should be equally efficacious. There is already considerable experience using this dosage scheme in heart failure patients locally.
The hemodynamic profile of PDE-5 inhibitors is favorable with reduction in filling pressures, both systemic and pulmonary, vascular resistance accompanied by improvement in symptoms and sub maximal and peak exercise performance. This pilot study will evaluate the use of the PDE5-inhibitor sildenafil in patients with heart failure, systolic dysfunction and documented secondary pulmonary hypertension.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 25 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Hartford Hospital is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: -
Sildenafil 40mgx3 daily for 6 months
Drug: Sildenafil
Placebo for Sildenafil 40mgx3 daily for 6 months
Drug: Placebo oral capsule
PDE5 Inhibitor
Placebo for Sildenafil
Six minute walk test
Analysis of change from the baseline
Time frame: Baseline, 8 weeks and 24 weeks
Patient Global Assessment (PGA)
Analysis of change form the baseline
Time frame: Baseline; 8 weeks and 24 weeks
1.Quality of Life (QoL) evaluation by EuroQol5D
Analysis of change from baseline
Time frame: Baseline, 8 weeks and 24 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Analysis of change from baseline
Time frame: Baseline, 8 weeks and 24 weeks
New York Heart Association (NYHA) function class
Analysis of change from baseline
Time frame: Baseline, 8 weeks and 24 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Started Feb 2018 (actual). Primary completion is estimated for Dec 2018, 10 months after the start.
Of 78 non-industry phase 3 interventional studies under Heart Failure, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 84. This study's planned 10 months is below that.
Counting every sponsor, half of 143 studies reached it within 39 months; a quarter within 25 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sildenafil