Heart failure with preserved left ventricular ejection fraction
Conditions
Interventions
Henggliflozin Combined with Probiotics Group:Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + clostridial enterococcus triple live tablet (400mg, 3 times/day) orally, for
Henggliflozin Monotherapy Group:Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks.
double placebo group:Primary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks.
Sponsors
The First Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=60 years; 2.Relevant investigations within 2 months meet diagnostic criteria for HFpEF: (1) Epidemiologic and population characteristics of patients with HFpEF; (2) Presence of symptoms and/or signs of heart failure; (3) Cardiac imaging suggests LVEF >=50%; (4) BNP>=35pg/ml and (or) NT-proBNP>=125pg/ml in sinus rhythm, and BNP>=105pg/ml and (or) NT-proBNP>=365pg/ml in atrial fibrillation; (5) At least one of the following conditions is met: 1) LVMI >=115 g/m^2 (male) or 95 g/m^2 (female); 2) LAVI >34 ml/m^2; 3) Relative wall thickness >0.42; or left ventricular free wall thickness >12mm; 4) E/e' >=14; 5) Ventricular septum e' 2.8m/s, or pulmonary artery systolic pressure >35mmHg; 3.NYHA class II to III for cardiac function; 4. Not taking SGLT-2 inhibitors within 6 months before enrollment; 5. No probiotic preparations taken within 3 months before enrollment; 6. The current anti-HF Therapeutic Regimen is well tolerated by patients and is stable for at least 1 month; 7. Currently stable HF with no acute exacerbations; 8. Cognitive Functioning is basically normal with comprehensible assessment scale content; 9. Possess basic behavioral ability, being able to perform daily activities independently or with the help of accessory aids; 10. Understand the purpose of the Clinical Study, voluntarily participate and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient's symptoms are due to noncardiac disease; 2. In those with contraindications to Henggliflozin: (1) Those who are allergic to henggliflozin; (2) Severe renal impairment (eGFR=50%) confirmed; 5. Valve replacement surgery within 6 months before enrollment; 6.Poor blood pressure control (SBP>=180mmHg or DBP>=100 mmHg); 7. Current acute decompensated heart failure requires treatment; 8. Resting heart rate exceeding 120 beats/min, or complicated by malignant Arrhythmia; 9. Significant coronary artery lesions require PCI revascularization; 10. Severe renal insufficiency (blood creatinine, Cr >442µmol/L) or receiving dialysis treatment; 11. Patients with urinary tract infection at entry; symptoms and signs of urinary tract infection, such as urinary tract irritation signs (frequent urination, painful urination, urgency), pain and tenderness above the pubic bone, fever, pain or percussion pain in the waist, etc., and urine bacterial culture colony counts >=105/ml; 12. Currently having a malignancy that requires treatment; 13. Current concurrent acute disease or acute exacerbation of chronic disease; 14.Participated in other interventional investigators within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kansas City Cardiomyopathy Quality of Life Questionnaire Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| New York Heart Association functional classification;6 minute walk distance;Minnesota Heart Failure Quality of Life Questionnaire Score;echocardiogram;Serum NT-proBNP Levels; | — |
Countries
China
Contacts
Public ContactSu Hui
The First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed