Pilot Study Lp299v Supplementation in Chronic Heart Failure

NCT05752760 | Completed

• 1 other identifier: 45284
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure, Diastolic; Heart Failure, Systolic; Heart Failure With Preserved Ejection Fraction

Keywords

Endothelial Function; Microbiome; Heart Failure; Ejection Fraction

Outcome Measures

Primary Outcomes (3)

• Maximal Oxygen Consumption (VO2Max)

  This is a measurement of exercise capacity

  12 weeks

• Brachial Artery Flow Mediated Dilation (FMD%)

  This is a measurement of endothelial function in the brachial artery

  12 weeks

• Carotid-Femoral Pulse Wave Velocity (cfPWV)

  Measurement of vascular stiffness

  12 weeks

Secondary Outcomes (7)

• Brachial Artery Absolute Flow Mediated Dilation (FMDmm)

  12 weeks

• Resting shear stress of brachial artery

  12 weeks

• Resting velocity

  12 weeks

• Change in serum Soluble Suppression Tumorigenesis (SST2)

  12 weeks

• Peak flow velocity

  12 weeks

Study Arms (2)

Lp299v

EXPERIMENTAL

Subjects will consume 20 billion colony forming units of Lp299v (2 capsules) once daily for 12 weeks.

Other: Lactobacillus Plantarum 299v Freeze Dried Capsule

Placebo Control

PLACEBO COMPARATOR

Subjects will consume potato starch (2 capsules) once daily for 12 weeks.

Other: Freeze Dried Potato Starch Capsule

Interventions

Lactobacillus Plantarum 299v Freeze Dried Capsule OTHER

The intervention is a probiotic lactobacillus that is contained in food products in the US

Lp299v

Freeze Dried Potato Starch Capsule OTHER

The intervention is potato starch that is freeze dried designed to mimic the lp299v capsule.

Placebo Control

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Advancing a Healthier Wisconsin: collaborator
• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (9)

• 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.

  PMID: 33566058 BACKGROUND

• 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.

  PMID: 27340274 BACKGROUND

• Wisconsin Heart Disease and Stroke Prevention Program, February 2010. www.dhs.wisconsin.gov/publications/p0/p00146.pdf

  BACKGROUND

• 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.

  PMID: 26682791 BACKGROUND

• 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.

  PMID: 33597583 BACKGROUND

• 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.

  PMID: 20198122 BACKGROUND

• 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.

  PMID: 10357875 BACKGROUND

• Spertus, J., Kansas City Cardiomyopathy Questionnaire MDDT decision summary. <fda.gov>

  BACKGROUND

• Thomas, R, Cohn, J., Minnesota Living with Heart Failure Questionnaire <license.umn.edu/product/minnesota-living-with-heart-fialure-questionnaire-mlhfq>

  BACKGROUND

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael E Widlansky, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, FACC, FAHA

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: February 20, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 1 year of completion of all studies procedures

Locations

US (1)