Sildenafil in US Heart Failure Patients (SilHF-US) (SilHF-US)
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|ClinicalTrials.gov Identifier: NCT03460470|
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Pulmonary Hypertension||Drug: Sildenafil Drug: Placebo oral capsule||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sildenafil in US Heart Failure Patients (SilHF-US)|
|Actual Study Start Date :||February 14, 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Sildenafil 40mgx3 daily
Sildenafil 40mgx3 daily for 6 months
Placebo Comparator: Placebo tablet x3 daily
Placebo for Sildenafil 40mgx3 daily for 6 months
Drug: Placebo oral capsule
Placebo for Sildenafil
- Six minute walk test [ Time Frame: Baseline, 8 weeks and 24 weeks ]Analysis of change from the baseline
- Patient Global Assessment (PGA) [ Time Frame: Baseline; 8 weeks and 24 weeks ]Analysis of change form the baseline
- 1.Quality of Life (QoL) evaluation by EuroQol5D [ Time Frame: Baseline, 8 weeks and 24 weeks ]Analysis of change from baseline
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, 8 weeks and 24 weeks ]Analysis of change from baseline
- New York Heart Association (NYHA) function class [ Time Frame: Baseline, 8 weeks and 24 weeks ]Analysis of change from baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460470
|Contact: Arben Ademi, CCRPfirstname.lastname@example.org|
|Contact: Konstadina Darsaklis, MD||860-972-1212||konstadina.Daraklis@hhchealth.org|
|United States, Connecticut|
|Hartford Hospital 80 Seymour street||Recruiting|
|Hartford, Connecticut, United States, 06102|
|Contact: Konstadina Darsaklis, MD 860-972-1212 email@example.com|
|Contact: Arben Ademi, CCRP 860-972-3561 firstname.lastname@example.org|
|Principal Investigator:||Konstadina Darsaklis, MD||Hartford Hospital|