What is a Clinical Trial?
Patient care advances rely on good clinical research. The National Heart, Lung and Blood Institute, part of the National Institutes of Health, is an important funding source for heart research in the United States. Below is information from their website, which provides additional information on who sponsors clinical trials, how they work and what people should expect when they participate in a clinical trial. For more information, please visit:
https://www.nhlbi.nih.gov/health/health-topics/topics/clinicaltrials/
Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best evidence to guide health care decisions.
The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable and interpretable study results.
Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas in molecules and cells.
If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed.
For safety purposes, clinical trials start with small groups of people, often healthy people, to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits in patients with the disease of interest.
It is important always in clinical trials to make sure that there is “equipoise” about the different strategies being tested, that is, doctors truly don’t know which approach is the better one. A clinical trial may find that a new strategy, treatment or device:
- Improves patient outcomes
- Offers no benefit
- Causes unexpected harm
All of these results are important because they advance medical knowledge and help improve patient care.
Please complete a UA Sarver Heart Center Cardiology Research Registry Information Form to learn about new clinical research studies for which you may be eligible.
ONGOING TRIALS:
MAGNITUDE
•Study question/purpose: Outcomes of NTLA-2001 (gene therapy) vs. placebo in patients with ATTR cardiac amyloidosis
•Sponsor: Intellia
•PI: D. Acharya
•Major Inclusion: ATTR amyloidosis with cardiac involvement
•Major Exclusion: Silencer therapy for ATTR amyloidosis
•Contact: Karina (kmcarrillo@Arizona.edu)
Human Coronary Artery Plaque Transcriptomes and Cardiovascular Risk Assessment (Cell Bank)
•Study question/purpose: Transcriptome analysis in patients undergoing percutaneous coronary intervention. mRNA collected from balloons used during PCI
•Sponsor: NIH
•PI: D. Acharya
•Major Inclusion: all elective and emergent PCIs at BUMC-T.
•Major Exclusion: drug-coated balloons
•Contact: Karina (kmcarrillo@arizona.edu)
Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI)
•Study question: Evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of AMI in subjects with a recent history of AMI
•Sponsor: Idorsia Pharmaceuticals
•PI: D. Acharya-àM Shanmugasundaram
•Major Inclusion: Adults with STEMI/NSTEMI within 4 weeks and multivessel CAD with additional risk factors
•Major Exclusion: Bleeding diatheses, remote MI, single vessel disease without additional CAD RF
•Contact:Karina (kmcarrillo@arizona.edu)
EMPOWER
•Study question: Evaluate symptom improvement and cardiac remodeling with a transcatheter mitral contouring system (Carrilon device/annuloplasty) vs. placebo in patients with heart failure and functional mitral regurgitation.
•Sponsor: Cardiac Dimensions
•PI: A. Chatterjee
•Major Inclusion: Symptomatic mild or greater mitral regurgitation, NYHA II-IV sx.
•Major Exclusion: Inotropes/IABP within last 30 days, HF hospitalization in last 30 days, anticipated LVAD/transplant
•Contact: Karina (kmcarrillo@arizona.edu)
REBIRTH
•Study question: Evaluate impact of bromocriptine therapy on myocardial recovery in women newly diagnosed with peripartum cardiomyopathy
•Sponsor: NHLBI
•PI: E. Juneman
•Major Inclusion:New diagnosis of PPCM, within 5 months post-partum
•Major Exclusion: Currently pregnant, Breastfeeding, Previous diagnosis of cardiomyopathy
•Contact: Karina (kmcarrillo@arizona.edu)
COSIRA II
•Study question: To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.
•Sponsor: Shockwave Medical Inc.
•PI: M. Corban
•Major Inclusion: persistent refractory angina pectoris classified as CCS Grade III or IV. Must be treated with maximally tolerated guideline-directed medical therapy.
•Major Exclusion: Recent successful revascularization by either CABG or PCI within six months prior to enrollment, NYHA Class III or IV, severe valvular disease
•Contact: Lizzette Cruz (marquez@arizona.edu)
DAL - 302
•Study question: Evaluate potential of Dalcetrapib to reduce occurrence of fatal and non-fatal myocardial infarction in subjects with a documented recent ACS & AA genotype in the ADCY9 gene
•Sponsor: DalCor Pharmaceuticals
•PI: M. Sundaram
•Major Inclusion: ACS (can be enrolled up to 3 months following index event)
•Major Exclusion: NYHA Class III or IV, clinically apparent liver disease, current alcohol or drug abuse
•Contact: Karina (kmcarrillo@arizona.edu)
GENE PHIT
•Study question: Evaluate safety and efficacy of a single dose of AB-1002 (gene therapy), administered via antegrade intracoronary artery infusion in patients with NICM, and NYHA Class III symptoms of HF
•Sponsor: Askbio
•PI: H. Sadek
•Major Inclusion: NICM, NYHA Class III, 15% <LVEF <35%
•Major Exclusion: ICM secondary to CAD, Liver disease, clinically significant MI within last 6 months
•Contact: Lizzette Cruz (marquez@arizona.edu)
•Expected to open in August
MUSIC HFrEF
•Study question: Evaluate safety and tolerability of a one-time intracoronary administration of SRD-001 (gene therapy) in subjects with HFrEF.
•Sponsor: Sardocor
•PI: H. Sadek
•Major Inclusion: Chronic ICM or NICM, LVEF <35%, Class III/IV HF
•Major Exclusion: IV therapy with positive inotrpoes, HCM, Untreated valvular disease, MI within 6 months prior
•Contact: Lizzette Cruz (marquez@arizona.edu )
•Expected to open in August
RECHARGE
•Study question: Compares effect of PCI vs. CABG on survival and improvement in QOL in Women and Minorities.
•Sponsor: Weill Cornell Medicine
•PI: K. Toshinobu/ A. Chatterjee
•Major Inclusion: Equipoise between CABG and PCI
•Major Exclusion: STEMI, Prior PCI within 1 year
•Contact: Lizzette Cruz (marquez@arizona.edu )
•Expected to open in August
INVESTIGATOR-INITATED REGISTRIES & BIOBANKS:
CRT Registry
•Study Question: Develop a prospective registry of patients with coronary epicardial and microvascular dysfunction to allow us to better understand the pathogenesis of CMD, the sequence of events from the diagnosis of microvascular dysfunction to time of development of MACE and the mechanism by which these events occur.
•Sponsor: N/A
•PI: M. Corban
•Major Inclusion: Patients presenting to Banner with symptoms of angina with ANOCA, INOCA or MINOCA
•Major Exclusion: Evidence of obstructive CAD
•Contact: Michel Corban
UA iPSC Study
•Study Question: The main purpose of this study is to create induced pluripotent stems (iPs) cells from healthy volunteers as well as patients with cardiac diseases and non-cardiac genetic diseases.
•Sponsor: N/A
•PI: H. Sadek
•Major Inclusion: Open to all patients
•Major Exclusion: Unable to provide informed consent
•Contact: Lizzette Cruz (marquez@arizona.edu)