Studies Recruiting Sites


AED01: Pharmacokinetics of Anti-epileptic Drugs in Obese Children

This is a prospective, multi-center clinical trial to characterize the safety and pharmacokinetics of four oral anti-epileptics drugs (levetiracetam, valproic acid, topiramate, and oxcarbazepine) in obese children and adolescents (ages 2-18 years old). The study's duration will be up to 14 days (up to seven days of screening and seven days of pharmacokinetic sampling).

ClinicalTrials.gov Identifier: NCT02993861
Sponsor:  NICHD
Recruiting: Sites and patients
Contact for Information:
Barrie Harper
barrie.harper@duke.edu
(919) 668-8291


AEGIS-II: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

AEGIS-II is a phase 3 Acute Coronary Syndrome study which will be evaluating the efficacy and safety of CSL112 on reducing the risk of major adverse cardiovascular events in high risk patients with ACS (diagnosed with STEMI or NSTEMI) who are receiving evidence-based medical therapy. The study is sponsored by CSL-Behring and is being managed in collaboration with global academic groups and a global CRO.

ClinicalTrials.gov Identifier: Not registered at this time
Sponsor: CSL Behring, LLC
Recruiting: Sites and patients
Contact for Information:
Anne Rosenberg
anne.rosenberg@duke.edu
(919) 668-0742


ARAMIS: Addressing Real-world Anticoagulant Management Issues in Stroke

The ARAMIS registry is designed to provide important and timely insight into the management of acute stroke patients who are on new oral anticoagulants in community practice.

ClinicalTrials.gov Identifier: NCT02478177
Sponsor: Janssen, Genentech, and Daiichi Sankyo
Recruiting: Patients
(*Sites must be participating in Get With the Guidelines -Stroke)
Contact for Information:
Khaula Baloch
khaula.baloch@duke.edu
(919) 668-8909


AUGUSTUS: Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valvular Atrial Fibrillation and Acute Coronary Syndrome/Percutaneous Coronary Intervention

The AUGUSTUS study is an open label, 2x2 factorial, randomized, controlled, clinical trial to evaluate the safety of apixaban versus vitamin K antagonist and aspirin versus aspirin placebo in patients with atrial fibrillation and acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI). It is designed to help determine the optimal antithrombotic strategy in patients with atrial fibrillation and ACS or PCI.

ClinicalTrials.gov Identifier: NCT02415400
Sponsors:
Bristol-Myers Squibb Research and Development
Pfizer, Inc.
Recruiting: Sites and patients at 590 centers in 33 countries
Contact for Information:
Jerry Kirchner
jerry.kirchner@duke.edu
(919) 668-7818


CARRA (Childhood Arthritis and Rheumatology Research Alliance) Registry: Observational Study of Pediatric Rheumatic Diseases

The CARRA Registry is an observational study of subjects with the onset of rheumatic disease prior to age 16 years for juvenile idiopathic arthritis and onset prior to age 19 years for all other rheumatic diseases.  The Registry will enroll 10,000 patients and follow the patients for a 10-year period. The data will be collected semi-annually. The primary objective is to prospectively collect essential data from children, adolescents and young adults with pediatric onset rheumatic diseases; and evaluate the safety of therapeutic agents in these subjects.

ClinicalTrials.gov Identifier: NCT02418442
Sponsor:  CARRA Inc.
Recruiting: Patients and evaluating select sites
Contact for Information:
Kristin Siebenaler
kristin.siebenaler@duke.edu
(919) 668-7830


CONNECT-HF: Care Optimization through Patient and Hospital Engagement Clinical Trial for Heart Failure

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial that will enroll 8,000 people with heart failure at 160 hospitals across the United States. The primary objective of CONNECT-HF is to evaluate the effect of two quality-improvement initiatives compared to usual care on HF outcomes and HF quality-of-care metrics at 1 year after discharge.

ClinicalTrials.gov Identifier: NCT03035474
Sponsor: Duke Clinical Research Institute funded by an independent investigator grant from Novartis
Recruiting: Sites and patients
Contact for Information:
Tracy Hofmann
DCRI-CONNECT-HF@dm.duke.edu
(919) 668-7544


EMPA-KIDNEY: A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease

The EMPA-KIDNEY trial will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with and without diabetes.

ClinicalTrials.gov Identifier: N/A
Sponsor: Boehringer Ingelheim
Recruiting: Sites and patients
Contact for Information:
Ty Rorick
tyrus.rorick@duke.edu
(919) 668-8683


HCV Heart and Lung Study: A Multicenter, Open-label Study of Harvoni ® (Sofosbuvir Ledipasvir Fixed Dose Combination) in Subjects Infected With Chronic Hepatitis C and Advanced Heart Failure or Lung Disease

This is a multicenter study in the U.S. of Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.

ClinicalTrials.gov Identifier: NCT02858180
Sponsor: Gilead
Recruiting: Patients
Contact for Information:
Lori Hudson, PhD, CCRP
lori.hudson@duke.edu
(919) 259-5579


HEART-FID: Heart Failure With Iron Deficiency

HEART-FID is a double-blind, multicenter, prospective, randomized, placebo-controlled study assessing the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo  in the treatment of patients with heart failure, iron deficiency and a reduced ejection fraction.

ClinicalTrials.gov Identifier: NCT03037931
Sponsor: Luitpold Pharmaceuticals
Recruiting: Sites and patients
Contact for Information:
Dianne Leloudis
dianne.leloudis@duke.edu
(919) 886-1426

Sharon Califf
sharon.califf@duke.edu
(919) 668-8425


MINT: Myocardial Ischemia and Transfusion. Patients with acute coronary syndrome (ACS) and a hemoglobin of less than 10 g/dL will be randomized to one of two transfusion thresholds: 8 g/dL or 10 g/dL.
ClinicalTrials.gov Identifier
Sponsor: NHLBI
Contact for Information:
Jeff Carson MD (carson@rwjms.rutgers.edu)
Helaine Noveck (noveck@rwjms.rutgers.edu)

Pediatric CABP Study: A Phase 2/3, Randomized, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 years of age, inclusive) and Children (≥2 months to <12 years of age) with Community-Acquired Bacterial Pneumonia (CABP)

ClinicalTrials.gov identifier: NCT02605122
Sponsor: Cempra, Inc
Recruiting: Sites
Contact for Information:
Erika Ratcliffe
erika.ratcliffe@duke.edu
(919) 668-6958


PRIME-HF: Predischarge Initiation of Ivabradine in the Management of Heart Failure

PRIME-HF is a multicenter, randomized, open-label study comparing pre-discharge initiation of ivabradine to usual care following a hospitalization for acute heart failure.

ClinicalTrials.gov Identifier: NCT02733185
Sponsor: Duke University
Recruiting: Patients
Contact for Information:
Lori Hudson, PhD, CCRP
Clinical Trials Project Leader
lori.hudson@duke.edu
(919) 259-5579


TACT2: Trial to Assess Chelation Therapy

TACT2 will build on the positive results of TACT1, an NIH-sponsored multicenter, double-blind efficacy and safety trial for edetate disodium (EDTA) chelation therapy in individuals with coronary artery disease. Plans for TACT2 include targeting the population of patients who received the greatest benefits from EDTA treatment (those with a prior heart attack and diabetes) and also to determine if the positive results from TACT1 can be replicated in diabetic patients who have experienced a myocardial infarction, a particularly high-risk group of patients in need of effective therapy.

ClinicalTrials.gov Identifier: NCT02733185
Sponsor: Mount Sinai Medical Center (Miami)
Recruiting: Sites and patients in U.S. and Canada
Contact for Information:
Wanda Parker, RN, MSN
wanda.parker@duke.edu
(919) 668-8589


TARGET-HFDM: Technology to improve drug Adherence and Reinforce Guideline based Exercise Targets in patients with Heart Failure and Diabetes Mellitus

TARGET-HFMD is a multi-site study in the U.S. evaluating the utility of mHealth tools to improve physical activity and medication adherence in patients with chronic heart failure and diabetes mellitus.

ClinicalTrials.gov Identifier: NCT02918175
Sponsor: American Heart Association
Recruiting: Patients
Contact for Information:
Lori Hudson, PhD, CCRP
lori.hudson@duke.edu
(919) 259-5579


TIM01: Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants with Infantile Hemangiomas (IH)

The primary objective of the study is to describe the efficacy of 0.25% and 0.5% topical timolol maleate gel forming solution (GFS) as assessed through IH changes in volume.  The secondary objective is to describe the safety and pharmacokinetics (PK) of topical timolol maleate GFS for treatment of IH.

ClinicalTrials.gov Identifier: NCT02913612
Sponsor:  NIH
Recruiting: Sites and patients
Contact for Information:
Chad Livingston
chad.livingston@duke.edu
(919) 668-1935


TRANSFORM-HF: ToRsemide compArisoN with furoSemide FORManagement of Heart Failure

TRANSFORM-HF will compare torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized.

ClinicalTrials.gov Identifier: NCT03296813
Sponsor: NIH/NHLBI
Recruiting: Sites
Contact for Information:
Ingrid Jones
ingrid.jones@duke.edu
(984) 227-4015


VIVID: Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs

VIVID is a clinical randomized trial using patient-centered racially distinct educational videos on Sudden Cardiac Death and ICD therapy in African American patients, comparing the effect of the video intervention vs. usual care, to look at the decision for ICD implantation and the effect of racial concordance on the decision for ICD implantation. VIVID is consenting, randomizing, collecting all PROs, and administering the video intervention via an iPad, using the VIVID iPad application.

ClinicalTrials.gov Identifier: NCT02819973
Sponsor: DCRI Investigator Initiated, PCORI funded
Recruiting: Patients (interested in potential future sites; recruiting African American patients over 18 months)
Contact for Information:
Laura Webb
laura.webb@duke.edu
(919) 668-8977