Clinical trial NCT01555320: Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure
Official title: Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF) A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Failure
Lead sponsor: State Administration of Traditional Chinese Medicine of the People's Republic of China
Sponsor class: OTHER_GOV
First posted: 2012-03-15
Enrollment: 640
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into two groups (treatment and control group) by central randomization service. The treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three times a day in addition to standardized western medications. Whereas the control group will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in addition to standardized western medications. Efficacy indicators include primary indicator (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause death, emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function classification; Minnesota life quality scale; scores from the four traditional chinese medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride, high density cholesterol and low density cholesterol. Safety indicators include blood pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th, 12th month after recruitment. All patients will be followed up until the end of study (Refers to the 12th month of the last case recruited into the study).


Eligibility criteria: Inclusion Criteria:

* Age 40 to 79
* Patients with ischemic heart failure：

  * LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
  * History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG);
  * Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure;
  * With or without dyspnea, fatigue and fluid retention (edema) etc.
* History of heart failure or present with heart failure symptoms for at least 3 months;
* New York Heart Association (NYHA) Class II to IV;
* Submitted informed consent

Exclusion Criteria:

* Acute heart failure or acute exacerbation of chronic heart failure
* Those who have one of the following diseases:

  * Acute coronary syndrome within 30 days
  * Revascularization therapy within 6 months
  * Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg
  * Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia
  * Dilated cardiomyopathy
  * Hypertrophic obstructive cardiomyopathy
  * Myocarditis
  * Pulmonary artery embolism
  * Severe valvular heart disease
  * Pulmonary heart disease
  * Stroke within 6 months
* Cardiac resynchronization therapy
* Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days
* Severe endocrine diseases such as hyperthyroidism, etc.
* History of malignant tumor
* Hemoglobin (HB )≤ 9g/dl
* Alanine aminotransferase (ALT) \> 2 times the upper limit of normal
* Serum creatinine \> 265 μmol/L
* Mental disorder
* Being pregnant, planning for pregnancy or breastfeeding
* Suspicious or definite allergy to intervention drugs
* Participated in other trials within 2 months
* Unable to walk autonomously due to physical disabilities

Primary outcomes:
measure: 6MWT distance
timeFrame: 0 month
measure: 6MWT
timeFrame: 3rd month
measure: 6MWT
timeFrame: 6th month
Secondary outcomes:
measure: Composite endpoint
timeFrame: 1st,3rd,6th,9th,12th month
measure: Brain natriuretic peptide (BNP)
timeFrame: 0,6th month
measure: Echocardiography
timeFrame: 0,6th month
measure: Cardiothoracic Ratio(CR)
timeFrame: 0,6th month
measure: Cardiac function classification, NYHA
timeFrame: 0,1st,3rd,6th,9th,12th month
measure: Minnesota life quality scale
timeFrame: 0,1st,3rd,6th,9th,12th month
measure: Scores from the four TCM diagnostic methods
timeFrame: 0,1st,3rd,6th,9th,12th month
measure: blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)
timeFrame: 0,3rd,6thmonth
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Guangdong
country: China
facility: Guangdong Provincial Hospital of TCM
state: Guangdong
city: Guiyang
country: China
facility: Second Affiliated Hospital of TCM College Guiyang
state: Guizhou
city: Baoding
country: China
facility: 252 Hospital of Chinese People's Liberation Army
state: Hebei
city: Heilongjiang
country: China
facility: The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of TCM
state: Henan
city: Hengyang
country: China
facility: The Affiliated Nanhua Hospital of Nanhua University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Traditional Chinese Medicine Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Hospital of T.C.M
state: Jiangsu
city: Nanchang
country: China
facility: The Affiliated Hospital of Jiangxi University of TCM
state: Jiangxi
city: Changchun
country: China
facility: The Affiliated Hospital To Changchun University of Chinese Medicine
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Xianyang
country: China
facility: Second Affiliated Hospital of Shaanxi University of Chinese Medicine
state: Shaanxi
city: Shandong
country: China
facility: Shandong Province Traditional Chinese Medicine University Affiliated Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Shuguang Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Traditional Chinese Medicine Hospital of Shan Xi Province
state: Shanxi
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of TCM
state: Sichuan
city: Tianjin
country: China
facility: Affiliated Hospital of Medical College of Chinese People's Armed Police Forces
state: Tianjin
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: Second Affiliated Hospital of Tianjin University of TCM
state: Tianjin
city: Tianjin
country: China
facility: The 2nd Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tian Jin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affliated Hospital
state: Tianjin
city: Urumqi
country: China
facility: Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region
state: Xinjiang
city: Anhui
country: China
facility: The First Affiliated Hospital of Anhui University of TCM
city: Beijing
country: China
facility: Dong Fang Hospital
Study officials:
affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Jingyuan Mao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hou YZ, Wang S, Zhao ZQ, Wang XL, Li B, Soh SB, Mao JY. Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF). Trials. 2013 May 14;14:138. doi: 10.1186/1745-6215-14-138.