Pilot Study Lp299v Supplementation in Chronic Heart Failure
Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure With Reduced and Preserved Ejection Fraction.
Medical College of Wisconsin
20 participants
Feb 20, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria17
- 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 allergy)
- Chronic Kidney Disease with eGFR ≤ 30 mL/min
- Hepatic Failure (Child's Class B or C)
- Patients with Gastrointestinal (GI) tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy, such that probiotic absorption would be altered
- Anticipated need for cardiac surgery during the projected study period for the subject
- Pregnancy
- Patients who are receiving Vitamin K antagonists such as Coumadin or Warfarin
- Neutropenia (Absolute Neutrophil Count (ANC) \< 1800/mm3)
- Inability to give informed consent or follow the study protocol
- On antibiotics at the time of enrollment or within one month of enrollment
- Currently taking a Lactobacillus based probiotic as an outpatient at the time of enrollment
- Patients who are unable to walk on treadmill or use a bicycle to participate in exercise testing
- Allergy to Lp299v probiotic supplement
Interventions
The intervention is a probiotic lactobacillus that is contained in food products in the US
The intervention is potato starch that is freeze dried designed to mimic the lp299v capsule.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05752760