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Study 1:

QUEST

QUEST: Electrical Nerve Block for Amputation Pain

The purpose of this clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with phantom limb pain and/or residual limb pain. The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50 percent reduction of pain score for more than 50 percent of all pain episodes.

Main inclusion/exclusion criteria:
A complete list of inclusion and exclusion criteria may be found at https://www.clinicaltrials.gov/ct2/show/NCT02221934?term=NEUROS&draw=2&rank=4 or contact the research coordinator by email at Mariana.Hurutado@BSWHealth.org.

Principal investigator: John F. Eidt, MD

For more information regarding enrollment in this trial, please contact Mariana Hurutado-Rodriguez at 214-820-7755.




Study 2:

SPIRRIT

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

The study will evaluate heart failure patients with preserved ejection fraction (HFPEF) in the Swedish Heart Failure Registry (2550 patients) and HFPEF patients in US (650 patients). HFPEF is defined as symptoms/signs of heart failure (HF), elevated NTproBNP (B-type Natriuretic Peptide; N-terminal pro b-type Natriuretic Peptide) and EF>=40%. Intervention and control: Randomized 1:1 to intervention: spironolactone + usual care vs. control: usual care alone.

Study Objectives: This study has one primary and several secondary outcome objectives. Primary outcome is cardiovascular death or time to HF hospitalization. Secondary outcomes include hospitalization for various causes, adverse events and treatment adherence. In Sweden outcomes are obtained automatically by linking with the Population, Patient and Drug Dispensed Registries. In the US, outcomes will be reported by sites and supplemented by data from a call center. The trial is event-driven with enrollment 3 years and study duration 5 years. For the primary outcome (CV Death or first HF hospitalization) with an event target of 632 events the sample size requires 3012 patients conservatively rounded to approximately 3200 patients. A detailed feasibility assessment shows that there will be > 8197 eligible patients to meet the required enrollment of 3200 patients.

“The SPIRRIT trial is focused specifically on patients with heart failure and a preserved ejection fraction,” said Timothy Gong, MD, a cardiologist specializing in advanced heart failure on the medical staff of Baylor Scott & White Heart and Vascular Hospital – Dallas and principal investigator for SPIRRIT. “I am interested in this trial because there are no therapies for these patients with a proven mortality benefit. I hope that a trial of this magnitude will shed light on future therapies for this disease.”

Main inclusion/exclusion criteria: A complete list of inclusion and exclusion criteria may be found at https://www.clinicaltrials.gov/ct2/show/NCT02901184?term=SPIRRIT&draw=2&rank=1

Principal investigator: Timothy Gong, MD
For more information regarding enrollment in this trial, please contact Shane.Blankenship@BSWHealth.org




Study 3:

Lp(a) in CVD Patients

Lipoprotein(a) in Patients With Cardiovascular Disease
This is a multi-center cross-sectional epidemiological study to estimate the prevalence (%) of patients with elevated Lp(a) in patients with established CVD defined by their medical history. One study visit is planned for data collection. Relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period will be collected retrospectively. In the event that laboratory data are not available, blood sampling will be performed.

Study Objective: The study will be conducted using one study visit and analyzing participants’ relevant medical history and laboratory values for LDL-cholesterol (LDL-C) and Lp(a) within a past pre-specified period. In case laboratory data are not available, blood sampling will be performed.

“Individuals with established cardiovascular disease (CVD) often have elevated levels of lipoprotein(a),” said Cara East, MD, FAPCR, FACP, FACC, Director of Soltero Cardiovascular Research Center, a cardiologist on the medical staff of Baylor Scott & White Health, and the study’s principal investigator. “The study is looking at levels of Lp(a) which is a novel cholesterol particle which causes hardening of the arteries. This study aims to see how many patients with heart disease have high Lp(a) levels.”

Main inclusion/exclusion criteria: A complete list of inclusion and exclusion criteria may be found at https://clinicaltrials.gov/ct2/show/NCT03887520?term=CTQJ230A12001&draw=2&rank=1

Principal investigator: Cara East, MD, FAPCR, FACP, FACC For more information regarding enrollment in this trial, please contact Shanet Stefanos, Shanet.Stefanos@BSWHealth.org, or call Soltero Cardiovascular Research at 214.820.2273.



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