Pilot Study Lp299v Supplementation in Chronic Heart Failure

Launched by MEDICAL COLLEGE OF WISCONSIN · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether a probiotic supplement called Lp299v can improve the health and quality of life of people with heart failure. Specifically, it will study how taking this probiotic for 12 weeks affects exercise ability, heart health markers in the blood, and overall well-being in adults who have heart failure with either reduced or preserved heart function and who show signs of inflammation. The study will be conducted in a fair way, where neither the participants nor the researchers will know who is receiving the probiotic and who is receiving a placebo (a non-active pill).

To be eligible for this study, participants need to be between 21 and 89 years old and have been diagnosed with heart failure in the past six months. They should also have certain heart test results that show how well their heart is pumping blood. However, there are some health conditions that would exclude someone from participating, such as certain types of severe heart valve disease, cancer with a short life expectancy, or certain lung and kidney diseases. If someone qualifies and joins the study, they can expect to take either the probiotic or a placebo daily and undergo tests to measure their heart function and overall health during the study.

Gender

ALL

Eligibility criteria

• 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