The Study of Qishenyiqi Drop Pills in Improving the Prognosis of Heart Failure Patients

NCT04028544 | Unknown Phase 4 DMC

• 1 other identifier: 2015-ZX55
• Study Type: interventional
• Target: 5,380
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study including patients with ejection fraction decreased heart failure under standardized treatment, to evaluate QiShenYiQi (QSYQ) dropping pill's curative effect in reducing cardiovascular death and heart failure rehospitalization compared with placebo.

Conditions

Heart Failure

Keywords

heart failure; traditional Chinese medicine; prognosis; Qishenyiqi

Outcome Measures

Primary Outcomes (1)

• Time to the occurrence of cardiovascular (CV) death or heart failure (HF) re-hospitalization.

  Compared with placebo, whether QSYQ prolong the occurrence of CV death or HF re-hospitalization of patients with chronic heart failure with lower ejection fraction (HFrEF). The treatment arm with the delayed events happening will be deemed as having a successful response.

  up to 30 months

Secondary Outcomes (8)

• Time to the occurrence of all-cause death.

  up to 30 months

• Time to the occurrence of all-cause death or HF re-hospitalization.

  up to 30 months

• Time to the occurrence of CV death.

  up to 30 months

• Time to the occurrence of total HF re-hospitalization.

  up to 30 months

• Time to the occurrence of composite endpoint.

  up to 30 months

Other Outcomes (8)

• Time to the occurrence of HF death.

  up to 30 months

• Time to the occurrence of total re-hospitalization for nonfatal myocardial infarction and nonfatal stroke.

  up to 30 months

• The improvement of Kansas City Cardiomyopathy Questionnaire (KCCQ) score and sub-domain score.

  up to 30 months

Study Arms (2)

The Treatment Group

EXPERIMENTAL

standard treatment + Qishenyiqi dropping pills (QSYQ) (oral use, 1 bag each time, three times a day)

Drug: Qishenyiqi dropping pills

The Control Group

PLACEBO COMPARATOR

standard treatment + placebo (oral use, 1 bag each time, three times a day).

Drug: Placebo

Interventions

Qishenyiqi dropping pills DRUG

on the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day

Also known as: QSYQ

The Treatment Group

Placebo DRUG

on the basis of standard treatment, adding placebo 1 bag each time, 3 times a day

Also known as: Placebo for QSYQ

The Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the requirements of the study and willingness to provide written informed consent.
• Male or female subjects aged ≥ 18 years
• Patients with ejection fraction decreased heart failure (NYHA II-IV, Echocardiography with Simpson method within four weeks and NT-proBNP within two weeks before random) （1）35%≤LVEF≤40% ; NT-proBNP≥900pg/ml, patients with renal dysfunction (glomerular filtration rate \<60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥1200 pg/ml； （2）LVEF\<35% (Simpson method); NT-proBNP≥600pg/ml, patients with renal dysfunction (glomerular filtration rate \<60 ml/min/1.73m2）or atrial fibrillation, the NT-proBNP should be ≥900 pg/ml.
• A history of hospitalization or emergency treatment for heart failure in the past two years and a diagnosis of heart failure at least one month ago
• The use of medications in line with the recommendation of China heart failure treatment guidelines for at least 4 weeks. (Please confirm that all the following conditions must be met) : Including a ACEI or ARB, and a beta- blocker, unless contraindicated or not tolerated. The doses should reach the target dose recommended by the guideline or the maximum dose that the patient can tolerate, and the doses should not be changed within one months prior to screening and randomization (patients not take such drugs according to the guidelines, should be recorded).

You may not qualify if:

• Acute decompensated HF with hemodynamic instability, mechanical hemodynamic support or invasive mechanical ventilation within 14 days of randomization, using intravenous positive inotropic drugs, vasoactive drugs and intravenous diuretics within 7 days before randomization.
• Poorly controlled hypertension, defined as resting systolic blood pressure≥180mmHg and /or diastolic blood pressure ≥110mmHg assessed on two separate occasions prior to randomization.
• Liver transaminase (ALT or AST), bilirubin more than 3 times the upper limit of normal not caused by heart failure, glomerular filtration rate\<15ml/min/1.73m2.
• Hemoglobin concentration ≤ 9.0g/dl and/or have blood system disease.
• Valvular heart disease, congenital heart disease without surgery.
• Cardiac shock.
• Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, other secondary and invasive cardiomyopathy.
• Active myocarditis.
• Constrictive pericarditis, other pericardial diseases.
• Syncope within 3 months.
• Symptomatic bradycardia or II or III degrees heart block without a pacemaker.
• Ventricular arrhythmias affecting hemodynamics.
• Cardiac resynchronization therapy implanted pacemaker (CRT-P) or cardiac resynchronization therapy defibrillators (CRT-D) within 6 months, or upgrade the existing conventional pacemaker or implantable implantable defibrillator (ICD) to the CRT device, or have the intention to implant similar devices.
• Occurred within 3 months: acute coronary syndrome, stroke, transient ischemic attack; Heart, carotid artery or other large vascular surgery; Percutaneous coronary intervention (PCI) or carotid artery angioplasty, CABG or other cardiac surgery.
• Major surgery within 6 months prior to randomization.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Tianjin Tasly Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jian Zhang, MD

  Heart Failure Center, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of the heart failure center

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: July 22, 2019
• Study Start: March 26, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: July 22, 2019

Record last verified: 2019-06

Locations

CN (1)