Contacting Institutional Review Board (IRB)
Trials that are conducted at Renown Health are reviewed by an Institutional Review Board (IRB), a group of people that reviews human research studies. The Renown Research Office works with several IRBs for research oversight, including:
- University of Nevada, Reno Office of Research Integrity
- Western Institutional Review Board (WIRB)
To discuss a problem or complaint, or ask about your rights as a research participant call us at 775-982-7843 and we would be happy to connect you with the appropriate IRB official.
DAPA ACT HF-TIMIDAPA ACT HF-TIMI is an international, multicenter, parallel-group, randomized, double-blind, placebo-controlled trial in patients with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤40%) who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure. Participation will last 2 months.
RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed to demonstrate the effectiveness and safety of the Paradise Renal Denervation System in hypertensive subjects. The ReCor Medical Paradise® Renal Denervation System (Paradise System) is a catheter-based system that delivers ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The goal of renal nerve ablation is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end organ damage. Subjects will be followed for 36 months post procedure. Included in the follow up visits are renal ultrasound, renal CT-Angiogram, lab, office blood pressure, drug escalation if needed, and 24 hour ambulatory blood pressure monitoring.
GUIDE-HF is a prospective, multi-center, randomized, dual arm, single-blind, controlled, interventional clinical trial intended to demonstrate the effectiveness of the CardioMEMS™ HF System to manage heart failure in an expanded patient population outside of the present indication. The CardioMEMS HF System consists of a pressure sensor implanted into the pulmonary artery and an external electronics that transmits pulmonary artery pressure measurements to a secure website. Healthcare professionals are able to access these measurements to guide individualization of medical management for their patients with chronic HF with the goal of reducing recurrent HFH and symptoms of heart failure. The study population will consist of 3600 people >18 years of age; New York Heart Association Class II, III, or IV; with either a heart failure hospitalization(HFH) within the last year or an elevated NTproBNP/BNP lab value within the last 30 days. After device implantation, subjects will be followed for 12 months through phone calls and clinic visits at 6 &12 months.
Paraglide HF is a multicenter, randomized, double-blind, double-dummy, parallel group, active controlled Phase IIIb drug study to evaluate the effectof sacubitril/valsartan versus valsartan on changes in NTproBNP and outcomes, safety, and tolerability in HFpEF patients (left ventricular ejection fraction (LVEF) > 40%) with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization and initiated in-hospital or within 30 days post-discharge (PARAGLIDE-HF). The purpose of the study is to assess the effect of sacubitril/valsartan on NTproBNP lab values from baseline to 4 and 8 weeks; changes in renal function; HF hospitalizations and urgent HF visits. The study population will consist of 800 male and female patients ≥ 40 years of age. Medication dosing will be 2 pills twice a day with duration of treatment from 8 weeks (minimum) to approximately 20 months.
Perspective is a phase 3 multicenter, randomized, double-blind, active-controlled study to evaluate the effects of valsartan/sacubitril compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. The Primary Objective is to evaluate the effects of valsartan/sacubitril compared to valsartan on cognitive function over 3 years in patients with HFpEF as assessed by the CogState cognitive assessment battery. The study population will consist of 520 patients ≥ 60 years of age with chronic symptomatic HF New York Heart Association class II-IV and left ventricular ejection fraction > 40%.
RADIANCE-HTN is a randomized, double-blind, sham controlled, designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in hypertensive subjects. The purpose of the RADIANCE-HTN study is to demonstrate the ability of the Paradise System to effectively reduce systolic daytime ambulatory BP (ABP) in hypertensive subjects with uncontrolled, treatment resistant hypertension despite at least three antihypertensive drugs of different classes including a diuretic. In addition the study is designed to document the safety profile of the Paradise System in all treated subjects. The Primary Efficacy endpoint will be collected at 2 months post procedure. Subjects will be followed for 3 years with visits once per month for 6 months, at 12 months, 24 and 36 months post procedure. Follow up surveillance will include CT, renal ultrasound, labs, office blood pressures and 24 hour ambulatory monitoring.
Follow-up Imaging After ThrombolysisThe purpose of the FIAT study is to investigate whether undergoing a head CT scan, changes clinical care and health outcomes among adults who have had a stroke. Patients are randomized to either undergo a head CT scan (standard of care) or to the research group which will not receive the head CT scan. This study's goal is to provide information which will reduce treatment burdens for patients and healthcare providers, reduce the radiation that stroke patients are exposed to during CT scans, and improve patient outcomes. The study population includes adults 18 years or older who received IV thrombolytics for an acute ischemic stroke and have an NIHSS less than 10 after administration of thromobolytics. Patients participate in this study for 3 months; in-patient procedures described above and a 3-month follow-up call.
Recruiting - Call 775-982-3646
Optimal Post rTpa-Iv Monitoring in acute Ischemic STroke (OPTIMIST)main- NeurologyThe purpose of the OPTIMISTmain study is to investigate if lower intensity nursing monitoring is at least as effective and safe as standard high intensity monitoring for patients who receive IV thrombolysis treatment for acute ischemic stroke. This phase III(b), multicenter, double-blind, stepped wedge cluster randomized control trial also seeks to understand the economic and resource benefits provided by less-intense post-IVT monitoring for a specific subset of acute ischemic stroke patients, those with an NIHSS <10 post IV Alteplase treatment without a clinical need for ICU care. Participants must be at least 18 years or older to participate in this 90 day duration study, with only in-patient assessments required upon enrollment and a phone follow-up at 90 days.
Recruiting - NCT03734640
As the largest healthcare system in northern Nevada and eastern California, and in partnership with the National Cancer Institute and the Nevada Cancer Research Foundation, we have access to dozens of open clinical trials.
We provide education and guidance to help patients make decisions about their care and treatment. Our specially trained research nurses and coordinators will help you understand the process and explain what to expect with each visit. We are committed to bringing the highest quality of cancer care to you and your loved ones.
AIRVO Device Intervention for Moderate to Severe COPD – Pilot Study (AIRVO)
This is an open (non-blinded), single-arm, clinical trial to assess the efficacy of daily use of a high-flow nasal cannula (HFNC) device in patients with moderate to severe chronic obstructive pulmonary disease (COPD) in reducing the amount of COPD exacerbations over a one-year period. All participants will be given their own device to use daily at home, with the option to keep the device at the end of the study if interested. Follow-up visits with study staff will be conducted five times throughout the one-year study enrollment period at Renown's pulmonary clinic.
Screening for SARS-CoV-2 Immune Plasma - Infectious DiseaseThe purpose of this study is to collect blood samples from adults who have recovered from the COVID-19 virus to measure their immune system response and to evaluate if they might be able to donate your blood plasma to treat others who have COVID-19. We hope to learn about the body's immune response to COVID-19 over time, and also assist individuals who are interesting in donating plasma through that process. Participation in this research will last about 1 year, with blood collection over time (up to 5 times over 1 year) to look at how antibodies and other immune responses change over time. Participation in this trial also includes the opportunity to participate in a sub-study assessing a new rapid COVID-19 test. If you are interested in participating in this study, please contact the research coordinator team at 775-982-6345 or CovidPlasmaScreening@renown.org Recruiting - Call 775-982-6345
A multicenter, adaptive, prospective, randomized trial evaluating the efficacy and safety of antithrombotic strategies in patients with COVID-19 following hospital discharge (ACTIV-4c) - Infectious DiseaseACTIV-4c is a multicenter, Phase III, adaptive trial designed to compare the effectiveness and safety of antithrombotic therapy against no antithrombotic therapy post-discharge among COVID-19 patients who were hospitalized for at least 48 hours. Participants must be at least 18 years of age, and participation in this study will last a duration of 90 days. Once the participant is discharged, they will complete telephone visits through the follow-up period.
Recruiting - NCT04650087
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19 (REDPINE) - Infectious DiseaseThe purpose of this Phase III, randomized, placebo-controlled study is to evaluate the efficacy and safety of Remdesivir therapy among patients hospitalized with COVID-19 experiencing severely reduced kidney function. Participants will receive a 5 day treatment of either Remdesivir or a saline placebo. Participants must be at least 12 years of age, and participation in this study will last a duration of 60 days. Once the participant is discharged, they will complete telephone visits through the follow-up period.
Recruiting - NCT04745351