NCT05752760 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Agarwal MA, Fonarow GC, Ziaeian B
National Trends in Heart Failure Hospitalizations and Readmissions From 2010 to 2017. JAMA Cardiol. 2021 Aug 1;6(8):952-956. doi: 10.1001/jamacardio.2020.7472.
Dick SA, Epelman S
Chronic Heart Failure and Inflammation: What Do We Really Know? Circ Res. 2016 Jun 24;119(1):159-76. doi: 10.1161/CIRCRESAHA.116.308030.
Hofeld BC, Puppala VK, Tyagi S, Ahn KW, Anger A, Jia S, Salzman NH, Hessner MJ, Widlansky ME
Lactobacillus plantarum 299v probiotic supplementation in men with stable coronary artery disease suppresses systemic inflammation. Sci Rep. 2021 Feb 17;11(1):3972. doi: 10.1038/s41598-021-83252-7.
Iikuni N, Lam QL, Lu L, Matarese G, La Cava A
Leptin and Inflammation. Curr Immunol Rev. 2008 May 1;4(2):70-79. doi: 10.2174/157339508784325046.
Pasini E, Aquilani R, Testa C, Baiardi P, Angioletti S, Boschi F, Verri M, Dioguardi F
Pathogenic Gut Flora in Patients With Chronic Heart Failure. JACC Heart Fail. 2016 Mar;4(3):220-7. doi: 10.1016/j.jchf.2015.10.009. Epub 2015 Dec 9.
Santos-Alvarez J, Goberna R, Sanchez-Margalet V
Human leptin stimulates proliferation and activation of human circulating monocytes. Cell Immunol. 1999 May 25;194(1):6-11. doi: 10.1006/cimm.1999.1490.
Spertus, J
, Kansas City Cardiomyopathy Questionnaire MDDT decision summary.
Thomas, R, Cohn, J
, Minnesota Living with Heart Failure Questionnaire
Wisconsin Heart Disease and Stroke Prevention Program, February 2010
www.dhs.wisconsin.gov/publications/p0/p00146.pdf

Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure With Reduced and Preserved Ejection Fraction.

Details for clinical trial NCT05752760

Clinical trial NCT05752760 - References