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Clinical study of probiotics in the treatment of heart failure with preserved ejection fraction in the elderly

Clinical study of probiotics in the treatment of heart failure with preserved ejection fraction in the elderly

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062725
Enrollment
Unknown
Registered
2022-08-16
Start date
2022-08-22
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with preserved ejection fraction

Interventions

intervention group:Take probiotics for 12 weeks
control group:blank

Sponsors

The First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 60 years old; 2. HFpEF has been clearly diagnosed, LVEF>= 50%; 3. cardiac function NYHA class II~III; 4. The current condition is stable without acute exacerbation; 5. Normal cognitive function; 6. Understand the purpose of the clinical trial, voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to Clostridium butyricum Enterococcus triple viable tablet; 2. MI, CABG or any event that may lower LVEF within 6 months prior to screening (unless LVEF >= 50% confirmed); 3. Poor blood pressure control (SBP>= 180mmHg or DBP>= 100mmHg); 4. Current acute decompensated heart failure requiring treatment; 5. Resting heart rate over 120 beats/min, or complicated with malignant arrhythmia; 6. Significant coronary artery disease requiring PCI revascularization; 7. Cardiopulmonary examination contraindications; 8. Severe renal insufficiency (serum creatinine > 442 µmol/L) or receiving dialysis treatment; 9. Concurrent with other serious acute and chronic diseases; 10. Mental disorder or cognitive dysfunction.

Design outcomes

Primary

MeasureTime frame
NT-proBNP;Minnesota living with heart failure questionnaire (MLHFQ);6 Minute Walk Distance;Heart function classification of NYHA;echocardiographic left atrial volume index(LAVI);MRI myocardial fibrosis index;blood inflammatory markers;

Secondary

MeasureTime frame
Gut Microbiome;Physical function assessment;frailty assessment;sarcopenia assessment;Nutritional assessment;

Countries

China

Contacts

Public ContactHui Su

The First Affiliated Hospital of the Air Force Medical University

Huisu2014@163.com+86 13609295016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026