Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT05752760
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
89 Years
Study:
NCT05752760
Study Brief:
Protocol Section:
NCT05752760