Clinical trial NCT06158711: Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure
Official title: A Retrospective Study of the Effect of Different Drugs Co-administration in the Treatment of Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The hospitalized patients who were treated in the First Affiliated Hospital of Shandong First Medical School from January 2013.to October 2023

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The B-type natriuretic peptide (BNP)
timeFrame: Admission to hospital and 12 months thereafter
measure: Left ventricular ejection fraction (LVEF) of patients
timeFrame: Admission to hospital and 12 months thereafter
measure: Hospital mortality
timeFrame: Index hospital stay
Secondary outcomes:
measure: Days of hospitalization and expenses of patients
timeFrame: Index hospital stay
measure: degree of lower limb edema (mild, moderate, severe)
timeFrame: Admission to hospital and 12 months thereafter
measure: 6-minute walking test
timeFrame: Admission to hospital and 12 months thereafter
Other outcomes:
Locations:
Study officials:
affiliation: Qianfoshan Hospital
name: Guang Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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