RECRUITING

Pilot Study Lp299v Supplementation in Chronic Heart Failure

Conditions

Heart Failure Heart Failure with Reduced Ejection Fraction Heart Failure, Systolic Heart Failure with Preserved Ejection Fraction Heart Failure, Diastolic Endothelial Function Microbiome Ejection Fraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Lactobacillus Plantarum 299v Probiotic Supplementation on Vascular Function and Exercise Capacity in Chronic Heart Failure with Reduced and Preserved Ejection Fraction.

Quick Facts

Study Start:2023-02-20

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05752760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Michael E Widlansky, MD

CONTACT

414-955-6759

mwidlans@mcw.edu

Michael M Aljadah, MD

CONTACT

414-955-6982

maljadah@mcw.edu

Principal Investigator

Michael E Widlansky, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Michael E Widlansky, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

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

Study Start Date2023-02-20

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2023-02-20

Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

Endothelial Function
Microbiome
Heart Failure
Ejection Fraction

Additional Relevant MeSH Terms

Heart Failure
Heart Failure with Reduced Ejection Fraction
Heart Failure, Systolic
Heart Failure with Preserved Ejection Fraction
Heart Failure, Diastolic