PMID- 32925713
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20240329
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 99
IP  - 37
DP  - 2020 Sep 11
TI  - Research based on the core pathogenesis in the treatment according to traditional 
      Chinese medicine syndrome differentiation for heart failure with normal ejection 
      fraction.
PG  - e21663
LID - 10.1097/MD.0000000000021663 [doi]
LID - e21663
AB  - BACKGROUND: The incidence of heart failure with normal ejection fraction (HFNEF) 
      is increasing yearly, accounting for approximately half of all heart failure 
      cases. Even after standardized treatment, the patient's prognosis is not good. 
      Therefore, it is necessary to explore new treatment methods for HFNEF. Yangyin 
      Shuxin Decoction, a traditional Chinese medicine prescription from our clinical 
      experience in the treatment of HFNEF, has a potential cardioprotective effect. 
      Preliminary clinical trials have shown that this prescription can improve the 
      quality of life of HFNEF. This prompted us to use more objective indicators to 
      further evaluate whether Yangyin Shuxin Decoction can improve the exercise 
      capacity in HENEF patients. METHODS: This is a single-center parallel randomized 
      controlled trial. The 64 patients who met the inclusion criteria were from the 
      Cardiovascular Clinic. They will be randomly assigned to the treatment group 
      (Yangying Shuxin Decoction combined with standard treatment) or the control group 
      (standard treatment) according to the ratio of 1:1. The course of treatment will 
      be 2 weeks. Both groups were interviewed at the following time points: of at 
      enrollment (V1), and week 2 (V2), week 4 (V3), week 8 (V4), and week 12 (V5) 
      after enrollment. The primary indicator is the peak oxygen consumption (Peak VO2) 
      of the cardiopulmonary exercise test (CPET). Secondary indicators include CPET 
      indicators such as anaerobic threshold oxygen consumption, carbon dioxide 
      ventilation equivalent slope, echocardiographic indicators such as the ratio of 
      mitral peak velocity of early filling to early diastolic mitral annular 
      velocity(E/e'), left atrial volume index (LAVI), left ventricular mass index 
      (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic 
      peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so 
      on. These indicators will be used to evaluate the effect of Yangyin Shuxin 
      Decoction on exercise capacity in patients with HFNEF. DISCUSSION: At present, it 
      is unclear whether the exercise capacity can be maintained after long-term use of 
      Yangyin Shuxin Decoction. In this study, we will evaluate whether Yangyin Shuxin 
      Decoction can improve the exercise capacity and quality of life of patients with 
      HFNEF. This will provide an objective basis for the therapeutic effect of 
      traditional Chinese medicine on HFNEF. TRIAL REGISTRATION: This study protocol 
      has been listed in the Chinese Clinical Trial Registry (registration number: 
      ChiCTR-IOR-17014206, http://www.chictr.org.cn/showproj.aspx?proj=24304) on 
      December 28, 2017.
FAU - Zhao, Zhiqiang
AU  - Zhao Z
AD  - Cardiovascular Department, First Teaching Hospital of Tianjin University of 
      Traditional Chinese Medicine, Tianjin, China.
FAU - Wang, Xianliang
AU  - Wang X
FAU - Wang, Shuai
AU  - Wang S
FAU - Zhou, Ruijuan
AU  - Zhou R
FAU - Su, Quan
AU  - Su Q
FAU - Liu, Yu
AU  - Liu Y
FAU - Cheng, Tao
AU  - Cheng T
FAU - Li, Qing
AU  - Li Q
FAU - Lin, Shanshan
AU  - Lin S
FAU - Liu, Hua
AU  - Liu H
FAU - Mao, Jingyuan
AU  - Mao J
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Drugs, Chinese Herbal/*therapeutic use
MH  - Echocardiography
MH  - Exercise Test
MH  - Exercise Tolerance
MH  - Female
MH  - Heart Failure/*drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Oxygen Consumption/drug effects
MH  - Prognosis
MH  - Randomized Controlled Trials as Topic
MH  - Stroke Volume/*physiology
MH  - Syndrome
MH  - Treatment Outcome
PMC - PMC7489596
COIS- The authors have no conflicts of interests to disclose.
EDAT- 2020/09/15 06:00
MHDA- 2020/09/25 06:00
PMCR- 2020/09/11
CRDT- 2020/09/14 15:44
PHST- 2020/09/14 15:44 [entrez]
PHST- 2020/09/15 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2020/09/11 00:00 [pmc-release]
AID - 00005792-202009110-00005 [pii]
AID - MD-D-20-06041 [pii]
AID - 10.1097/MD.0000000000021663 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2020 Sep 11;99(37):e21663. doi: 
      10.1097/MD.0000000000021663.