Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure

Study Overview
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Brief Summary
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The goal of this observational study is to assess the effect of the different combination of drugs in the treatment of heart failure. The main questions it aims to answer are: [question 1] The changes of BNP and LVEF in patients of each groups with different drugs co-administration. [question 2] The days of hospitalization, degree of lower limb edema (mild, moderate, severe) and 6-minute walking test in each groups. Participants will be asked to do nothing. All the records of the patients will be download from the Big Data Cloud Platform of Health Care in the First Affiliated Hospital of Shandong First Medical University. There is not a comparison group.

Detailed Description
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The purpose of this study is to evaluate the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure. For different reasons, patients with heart failure took different drug prescriptions. Now there are five kinds of drugs for the treatment of heart failure, such as angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACEI/ARB), beta-blokers, spironolactone, sodium-glucose cotransporter (sglt) 2 inhibitors and vericiguat. Our purpose is to assessment the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure.

Official Title
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A Retrospective Study of the Effect of Different Drugs Co-administration in the Treatment of Heart Failure

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as heart failure or cardiac insufficiency on the first page of the medical record Exclusion Criteria: Severe impairment of liver, kidney and lung function (transaminase increased more than 2 times; Scr > 265umol/L); malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single drug group, two drugs group, three drugs group and four drugs group<br>single drug group, patients with heart failure only took one sort of drugs two drugs group, patients with heart failure took two sorts of drugs three drugs group, patients with heart failure took three sorts of drugs four drugs group, patients with heart failure took four sorts of drugs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The B-type natriuretic peptide (BNP) | B-type natriuretic peptide (BNP) is a marker of heart failure. Its levels can be measured with a rapid and commercially available bed-side assay. Rising levels correlate with the degree of left ventricular dysfunction and severity of symptoms. | Admission to hospital and 12 months thereafter | 
| Left ventricular ejection fraction (LVEF) of patients | Echocardiography is the gold standard for establishing the presence of left ventricular dysfunction. Left ventricular ejection fraction (LVEF) is the central measure of left ventricular systolic function. LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). | Admission to hospital and 12 months thereafter | 
| Hospital mortality | We recorded the death from heart failure, no matter the mode of death. | Index hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of hospitalization and expenses of patients | The hospitalization days and expenses of patients admitted with different drugs treatment were examined. | Index hospital stay | 
| degree of lower limb edema (mild, moderate, severe) | Lower-extremity edema is one of the important factors in diagnosing, monitoring, and managing HF status. A senior cardiologist checked carefully for the presence of bilateral lower-extremity edema and graded its severity on a scale of 1 of 4 based on the extent of the edema in the leg, as follows: (1) none, (2) up to the height of the ankle level (mild edema), (3) up to the height of the knee (moderate edema), and (4) higher than knee level (severe edema). | Admission to hospital and 12 months thereafter | 
| 6-minute walking test | The 6-minute walking test (6MWT) is a widely available and well-tolerated test for the assessment of the functional capacity of patients with HF. | Admission to hospital and 12 months thereafter |