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The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction

The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000127
Enrollment
Unknown
Registered
2025-01-16
Start date
2023-09-14
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

atrial fibrillation and heart failure with preserved ejection fraction

Interventions

Observation group:Fumai decoction+OMT
Control group:placebo +OMT

Sponsors

Feng County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
46 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) age 46-80 years old; (2) Patients who met the diagnostic criteria of HFpEF with non-valvular AF were identified by medical history physical examination 12-lead electrocardiogram (ECG) and 24-hour Holter (Holter). BNP = 105 pg/ml or NT-proBNP = 365 pg/mL. Echocardiography showed any changes in cardiac structure or diastolic function. (3) HFpEF patients had not received standard treatment within one week before the study; (4) Informed consent was signed.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) Severe valvular congenital or rheumatic heart disease; hypertrophic obstructive cardiomyopathy; pericardial disease; hepatic or renal insufficiency; dehydration; inability to tolerate oral intake; persistent vomiting or diarrhea; fever; allergy to study medication; type 1 diabetes mellitus; history of diabetic ketoacidosis (DKA) while taking SGLT2i; malignancy; immune disorders; mental illness. (2) Inability or refusal to complete the study.

Design outcomes

Primary

MeasureTime frame
death;—

Secondary

MeasureTime frame
LVEF;NYHA cardiac function classification;The TCM syndrome score;The Kansas city cardiomyopathy questionnaire(KCCQ));NT-proBNP;Quality-of-life assessment of the Minnesota Living with Heart Failure Questionnaire (MLHF questionnaire);6-minute walk test (6MWT);CRP;Hospitalization for heart failure that resulted in an acute exacerbation of chronic heart failure that required hospitalization or an emergency department visit (with intravenous diuretics or vasoactive agents) during the course of the trial.;Patients who were readmitted due to other cardiovascular events .;E/e';sRAGE;—

Countries

China

Contacts

Public ContactDachang Xie

Feng County People's Hospital

15005214477@163.com15005214477

Outcome results

None listed

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