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). Identifier: NCT02993861
Sponsor:  NICHD
Recruiting: Sites and patients
Contact for Information:
Barrie Harper
(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. Identifier: Not registered at this time
Sponsor: CSL Behring, LLC
Recruiting: Sites and patients
Contact for Information:
Anne Rosenberg
(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. 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
(919) 668-8909

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. Identifier: NCT02418442
Sponsor:  CARRA Inc.
Recruiting: Patients and evaluating select sites
Contact for Information:
Kristin Siebenaler
(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. Identifier: NCT03035474
Sponsor: Duke Clinical Research Institute funded by an independent investigator grant from Novartis
Recruiting: Sites and patients
Contact for Information:
Tracy Hofmann
(919) 668-7544

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. Identifier: 
Sponsor: NHLBI
Contact for Information:
Jeff Carson MD (
Helaine Noveck (

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) identifier: NCT02605122
Sponsor: Cempra, Inc
Recruiting: Sites
Contact for Information:
Erika Ratcliffe
(919) 668-6958

SPIRRIT HFpEF: Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

SPIRRIT HFpEF is a unique pragmatic trial being implemented in both Sweden and the US. The protocol chair is Dr. Lars Lund of the Karolinska Institute in Sweden and co-chair, Dr. Bertram Pitt, University of Michigan. Heart failure with preserved ejection fraction (HFpEF) is common and deadly but without therapy. Inconclusive studies suggest spironolactone may be effective in HFpEF, but it is generic and is not studied by industry. SPIRRIT is a unique registry-randomized clinical trial that will test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of cardiovascular (CV) mortality and heart failure (HF) hospitalization. Identifier: NCT02901184
Sponsor: Uppsala Clinical Research Center
US Funding Support
National Heart, Lung, and Blood Institute (NHLBI)
Trial Innovation Network
Sites and patients in the U.S. and Sweden
Contact for Information:
Jacqueline Huvane, Ph.D., Project Leader
(919) 668-8282

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. Identifier: NCT02733185
Sponsor: Mount Sinai Medical Center (Miami)
Recruiting: Patients in U.S. and Canada
Contact for Information:
Wanda Parker, RN, MSN
(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. Identifier: NCT02918175
Sponsor: American Heart Association
Recruiting: Patients
Contact for Information:
Lori Hudson, PhD, CCRP
(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. Identifier: NCT02913612
Sponsor:  NIH
Recruiting: Sites and patients
Contact for Information:
Chad Livingston
(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. Identifier: NCT03296813
Sponsor: NIH/NHLBI
Recruiting: Sites and patients
Contact for Information:
Shelby Morgan
(336) 816-5266

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. 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
(919) 668-8977