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Kalispell Regional Healthcare

Active Studies

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Cancer

BREAST CANCER COLLABORATIVE REGISTRY
This registry will provide core support services for future multidisciplinary research on breast cancer and other chronic diseases.
Principal investigator: Melissa Hulvat, MD
Status: Open to enrollment

MERCK KEYNOTE-407
MK-3475-407-00
A randomized, double-blind, phase III study of carboplatin-paclitaxel/nab-paclitaxel chemotherapy with or without pembrolizumab (MK-3475) in first line metastatic squamous non-small cell lung cancer subjects.
Principal investigator: Elise Anderes, MD
Status: Open to enrollment

MIRACA REGISTRY
A registry of hematopoietic disease for evaluation and correlation with clinical outcomes.
Principal investigator: Peter Wagner, MD
Status: Open to enrollment

INCYTE MOST REGISTRY
Myelofibrosis and essential thrombocythemia observational study.
Principal investigator: Elise Anderes, MD
Status: Closed to enrollment (follow-up and data analysis)

REVEAL
Prospective, noninterventional study of disease progression and treatment of patients with polycythemia vera in United States academic or community clinical practice.
Principal investigator: Elise Anderes, MD
Status: Closed to enrollment (follow-up and data analysis)

Cardiology

ADAPTRESPONSE
The AdaptResponse study is a prospective, randomized, controlled, interventional, single-blinded, multicenter, post-market, global cardiac resynchronization therapy (CRT) in heart failure clinical study. The purpose of this clinical study is to test the hypothesis that market released CRT devices which contain the AdaptivCRT algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrioventricular conduction and left bundle branch block.
Principal investigator: Eve Gillespie, MD
Sponsor: Medtronic
Status: Closed to enrollment

CAMELLIA
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of long-term treatment with lorcaserin HCL on the incidence of major adverse cardiovascular events and conversion to Type 2 diabetes mellitus in obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors.
Principal investigator: Eve Gillespie, MD
Sponsor: Eisai, Inc.
Status: Closed to enrollment (interventions continue)

CHAMP HF
Observational registry of treatment patterns in U.S. heart failure patients with reduced ejection fraction.
Principal investigator: Eve Gillespie, MD
Sponsor: Novartis
Status: Closed to enrollment (follow-up and data analysis)

COMPASS
A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease.
Principal investigator: Eve Gillespie, MD
Sponsor: Bayer
Status: Closed to enrollment (interventions continue)

ODYSSEY
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome.
Principal investigator: Eve Gillespie, MD
Sponsor: Sanofi
Status: Closed to enrollment (interventions continue)

PARAGON
A multicenter, randomized, double-blind, parallel-group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA class II-IV) with preserved ejection fraction.
Principal investigator: Eve Gillespie, MD
Sponsor: Novartis
Status: Closed to enrollment (interventions continue)

PRE-DETERMINE
Biologic markers and sudden cardiac death study is a planned multicenter, prospective cohort study of patients with coronary artery disease with left ventricular function EF>35% who currently are at risk for sudden cardiac death, but do not fulfill criteria for implantable cardioverter defibrillator therapy.
Principal investigator: Eve Gillespie, MD
Sponsor: National Heart, Lung and Blood Institute and Brigham and Women’s Hospital
Status: Closed to enrollment (follow-up and data analysis)

Endocrinology

BEST
A double-blind, placebo-controlled study to evaluate the effects of bexagliflozin on hemoglobin A1c in patients with Type 2 diabetes and increased risk of cardiovascular adverse events.
Principal investigator: Jose de Souza
Status: Open to enrollment

CARMELINA
A multicenter, international, randomized, parallel group, double-blind, placebo-controlled cardiovascular safety and renal microvascular outcome study with linagliptin, 5 mg once daily in patients with Type 2 diabetes mellitus at high vascular risk.
Principal investigator: Jose de Souza
Status: Closed to enrollment (interventions continue)

DECLARE
Dapagliflozin effect on cardiovascular events – a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of dapagliflozin 10 mg once daily on the incidence of cardiovascular death, myocardial infarction or ischemic stroke in patients with Type 2 diabetes.
Principal investigator: Jose de Souza
Status: Closed to enrollment (interventions continue)

FOURIER OLE
A multicenter, open-label, single-arm extension study to assess long-term safety of evolocumab therapy in patients with clinically evident cardiovascular disease.
Principal investigator: Jose de Souza
Status: Closed to enrollment (interventions continue)

IDX-DR1
A multicenter study to evaluate performance of an automated device for the detection of diabetic retinopathy.
Principal investigator: Jose de Souza
Status: Open to enrollment

NN1250-4252
A trial comparing the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with Type 2 diabetes mellitus inadequately treated with basal insulin and oral antidiabetic drugs.
Principal investigator: Jose de Souza
Status: Open to enrollment

PROMINENT
Pemafibrate to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes.
Principal investigator: Jose de Souza
Status: Open to enrollment

REWIND
The effect of dulaglutide on major cardiovascular events in patients with Type 2 diabetes: researching cardiovascular events with a weekly incretin in diabetes.
Principal investigator: Jose de Souza
Status: Closed to enrollment (interventions continue)

THRESHOLD SUSPEND
Post-approval study of the TS (threshold suspend) feature with a sensor-augmented pump system.
Principal investigator: Jose de Souza
Status: Open to enrollment

Humanitarian Devices

SPIRATION IBV
The Spiration IBV valve system is a device to control prolonged air leaks, following lobectomy, segmentectomy or lung volume reduction surgery.
Principal investigator: Katarina Egressy, MD
Status: Humanitarian use device

GRAFTMASTER RX
Use of GRAFTMASTER RX coronary stent graft and GRAFTMASTER RX for the treatment of free perforation, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts >2.75mm in diameter.
Principal investigator: David Philips, MD
Status: Humanitarian use device

Rheumatology

CREDO 2
A randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter phase III study of the efficacy and safety of olokizumab in subjects with moderately to severely active rheumatoid arthritis inadequately controlled by methotrexate therapy.
Principal investigator: Roger Diegel
Status: Open to enrollment

CREDO 3
A randomized, double-blind, parallel-group, placebo-controlled, multicenter phase III study of the efficacy and safety of olokizumab in subjects with moderately to severely active rheumatoid arthritis inadequately controlled by tumor necrosis factor alpha inhibitor therapy.
Principal investigator: Roger Diegel
Status: Open to enrollment

HGS/GSK
A randomized, double-blind, placebo-controlled 52-week study to assess adverse events of special interest in adults with active, autoantibody-positive systemic lupus erythematosus receiving belimumab.
Principal investigator: Roger Diegel
Status: Open to enrollment

LILLY RHBE
A multicenter, randomized, double-blind, placebo-controlled 24-week study followed by long-term evaluation of efficacy and safety of ixekizumab (ly2439821) in biologic disease-modifying antirheumatic drug-experienced patients with active psoriatic arthritis
Principal investigator: Roger Diegel
Status: Closed to enrollment (interventions continue)

LILLY RHBF
A phase III, multicenter study with a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to week 104 to evaluate the long-term efficacy and safety of ixekizumab (LY2439821) 80 mg every two weeks in biologic disease-modifying antirheumatic drug–naive patients with active psoriatic arthritis.
Principal investigator: Roger Diegel
Status: Closed to enrollment (interventions continue)

LILLY RHBV
A multicenter, randomized, double-blind, active and placebo-controlled 16-week study followed by long term evaluation of efficacy and safety of ixekizumab (LY2439821) in bDMARD-naive patients with radiographic axial spondyloarthritis.
Principal investigator: Roger Diegel
Status: Open to enrollment

LILLY RHBX
A 52-week multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ixekizumab (LY2439821) in bDMARD-naive patients with nonradiographic axial spondyloarthritis.
Principal investigator: Roger Diegel
Status: Open to enrollment

LILLY RHBY
A multicenter, long-term extension study of 104 weeks, including a double-blind, placebo-controlled 40-week randomized withdrawal-retreatment period, to evaluate the maintenance of treatment effect of ixekizumab (LY2439821) in patients with axial spondyloarthritis.
Principal investigator: Roger Diegel
Status: Open to enrollment

PFIZER
A phase 3b/4 randomized safety endpoint study of two doses of tofacitinib in comparison to a tumor necrosis factor inhibitor in subjects with rheumatoid arthritis.
Principal investigator: Roger Diegel
Status: Open to enrollment

Other

BED STUDY
KRH caregiver satisfaction and improved safety outcomes: a mixed method evaluation study of “old” versus “new” bed systems.
Principal investigator: Jill Zemke
Status: Institutional research study

PRECEPTOR PROGRAM
Supporting the preceptors through a formalized preceptor program: a mixed method approach.
Principal investigator: Solimar Figueroa
Status: Institutional research study

THERASPHERE
A humanitarian device exemption use protocol of TheraSphere for treatment of unresectable hepatocellular carcinoma and hypervascular metastatic liver disease.
Principal investigator: Benjamin Pomerantz
Status: Humanitarian use device