Nationally Recognized Heart Hospital
Dallas   Fort Worth



Find a Physician

Advanced Search


Related Research

Topic 1:

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)
Research area:
Heart Failure
Principal investigator:
Shelley Hall, MD, FACC, FHFSA
Type of study:
Interventional

Study synopsis:
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

“Heart failure is the leading cause for hospitalization in patients over age 65. Through research we have learned that signs of deterioration occur inside the body 2-3 weeks prior to the patient having symptoms that they can notice or report. The Cardiomems device could detect and record these early signs, transmit to the physician office and thus trigger medical interventions capable of potentially preventing clinical deterioration. This technology could provide future heart failure patients with a potential new tool in aiding their recovery,” says Shelley Hall, MD, principal investigator.

Study objective:
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality. The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH). The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT03387813?term=NCT03387813&rank=1

Study contact:
Horacio Martinez, BS, CCRC, Horacio.Martinez@BSWHealth.org, 214.820.0338.




Topic 2:

QUARK 309

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery (QUARK 309)

A randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney injury following cardiac surgery.

Principle Investigator: Robert F. Hebeler, MD

Type of study: Interventional

Study Synopsis
This randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney injury following cardiac surgery. Patients will be given doses of QPI-1002 or placebo after the completion of cardiovascular surgery. The study will look at the following outcomes metrics: proportion of patients through day 90 who develop major adverse kidney events; proportion of patients developing AKI overall by modified AKIN criteria within five days post-surgery; renal function as estimated by glomerular filtration rate; proportion of subjects who die or initiate dialysis through day 90.

“Acute kidney injury is a fairly frequent occurrence after open heart surgery and can be anywhere from mild to severe with long-term adverse consequences to the patient. The QUARK study examines an agent researchers believe could prevent specific kidney injury following coronary artery bypass. This is a Phase 3 trial with the first two studies producing promising outcomes.” Robert Hebeler, MD, principal investigator.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria for the reduced ejection fraction study can be found at

https://www.clinicaltrials.gov/ct2/show/NCT03510897?term=QUARK+309&rank=1




Topic 3:

Empagliflozin Outcome Trial in Patients with Chronic Heart Failure with Reduced Ejection Fraction (EMPEROR-Reduced)
Research area:
Heart Failure
Principal investigator:
Cara East, MD, FACP, FAPCR
Type of study:
Interventional

Study synopsis:
The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure and either with reduced ejection fraction or preserved ejection fraction.

“While there are medications for the treatment of heart failure, 50% of patients with congestive heart failure will still die within five years. There is thus an unmet need for additional medications to treat heart failure. The medication Jardiance, invented for the treatment of diabetes, may have direct heart benefit, a premise that is being tested in these two trials,” says Cara East, MD, principal investigator.

Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria for the reduced ejection fraction study can be found at https://www.clinicaltrials.gov/ct2/show/NCT03057977?term=NCT03057977&rank=1

A complete list of inclusion and exclusion criteria for the preserved ejection fraction study can be found at https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT03057951&cntry=&state=&city=&dist=

Study contact:
Merielle Boatman, MBA, BAAS, Merielle.Boatman@BSWHealth.org, 214.820.2273.




Topic 4:

EMPEROR-Preserved

Summary: A Phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Empagliflozin outcome trial in patients with chronic heart failure (EMPEROR-Preserved)

Primary Investigator: Cara East, MD, Peter A. McCullough, MD.

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273



Back to Clinical Trials


Warning

Your Session will expire in 5 minutes

Please click the "Continue Session" button below to continue using the website. To end your session please click the "End Session" button below. After 5 minutes of inactivity your session will be terminated and you will be required to log in again.