Qishen Yiqi dripping pills for ischemic heart failure: A protocol for a prospective cohort study.

Abstract:

BACKGROUND:The prognosis of ischemic heart failure (IHF) is worse than non-IHM. Improving the management of IHF remains an urgent demand. In recent years, Qishen Yiqi dripping pills (QSYQ), a type of Chinese herbal medicine (CHM), has been popular for IHF combined with standard western medicine. However, relevant scientific evidence from the real clinical practice still is insufficient. The prospective cohort study aims to assess the effectiveness and safety of QSYQ plus standard western medicine for IHF in the real clinical practice. METHODS:It is a multicenter, prospective, observational cohort study. A total of 1200 patients with IHF recruited from 84 hospitals in China will be assigned to exposure group (patients with QSYQ treatment) or non-exposed group (patients without QSYQ treatment) mainly according to patients' preference in real clinical situation. The primary outcomes include New York Heart Association (NYHA) cardiac functional classification and Minnesota Living with Heart Failure Questionnaire (MLHFQ). The secondary outcomes include composite outcomes (all-cause mortality, frequency of re-admission or emergency due to cardiovascular events), left ventricular ejection fraction and cardiothoracic ratio, symptoms and signs obtained by the 4 Tradiational Chinese Medicine (TCM) diagnostic methods. Assessments will be performed at baseline, 1st and 3rd month after enrollment. DISCUSSION:It will provide new evidence on QSYQ for IHF in real clinical practice. STUDY REGISTRATION:This study has been registered on the Chinese Clinical Trial Registry (No: ChiCTR-ONRC-14004407).

journal_name

Medicine (Baltimore)

journal_title

Medicine

authors

Zhao Z,Wang X,Hou Y,Wang S,Zhai J,Wang C,Mao J,Zhang B

doi

10.1097/MD.0000000000013085

subject

Has Abstract

pub_date

2018-11-01 00:00:00

pages

e13085

issue

45

eissn

0025-7974

issn

1536-5964

pii

00005792-201811090-00033

journal_volume

97

pub_type

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