Pilot Study Lp299v Supplementation in Chronic Heart Failure (NCT05752760) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Lp299v Supplementation in Chronic Heart Failure
United States10 participantsStarted 2023-02-20
Plain-language summary
The goal of this study is to determine the impact of 12 weeks of Lp299v supplementation (20 million cfu/day vs. placebo) on exercise capacity, circulating biomarkers of cardiac remodeling, quality of life, and vascular endothelial function in humans with heart failure and reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) who have evidence of residual inflammation based on an elevated C-reactive protein level. This will be done in the setting of a randomized, double-blind, placebo-controlled trial.
Who can participate
Age range21 Years – 89 Years
SexALL
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Inclusion Criteria:
* Age between 21-89 years old
* Clinical diagnosis of Congestive Heart Failure (CHF) in the six months prior to enrollment along with an echocardiogram documenting systolic dysfunction with ejection fraction ≤40%
* Clinical diagnosis of CHF in the six months prior to enrollment along with an echocardiogram documenting diastolic dysfunction with an ejection fraction ≥50%, and a H2FpEFF score of ≥6
* New York Heart Association (NYHA) Class II-IIID heart failure symptoms with either ischemic or non-ischemic etiology OR similar diagnosis with congestive heart failure (CHF) along with an echocardiogram documenting an LV ejection fraction of 50% or more with similar NYHA classification as those with LVEF of 40% or less
* Evidence of systemic inflammation at baseline (C-reactive protein ≥ 2 mg/L at the time of screening)
Exclusion Criteria:
* Heart failure due to severe valve disease such as Aortic Stenosis, Mitral Regurgitation, or Mitral Stenosis
* Cancer besides non-melanoma skin carcinomas or localized prostate and breast cancer at the time of enrollment with life expectancy \<1 year
* Lung disease such as Chronic Obstructive Pulmonary Disease (COPD), emphysema, or Pulmonary fibrosis
* Active inflammatory disease or infectious disease at the time of enrollment
* Current treatment (or use within the past 14 days) of steroids or anti-inflammatory treatments (excluding non-steroidal anti-inflammatory medications or steroids used solely for IV contrast dye all…