Pilot Study Lp299v Supplementation in Chronic Heart Failure
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.
Conditions:
🦠 Heart Failure 🦠 Heart Failure With Reduced Ejection Fraction 🦠 Heart Failure, Systolic 🦠 Heart Failure With Preserved Ejection Fraction 🦠 Heart Failure, Diastolic
🗓️ Study Start (Actual) 20 February 2023
🗓️ Primary Completion (Estimated) 1 October 2024
✅ Study Completion (Estimated) 1 March 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    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 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
Ages Eligible for Study: 21 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 February 2023
  • First Submitted that Met QC Criteria 21 February 2023
  • First Posted 3 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024