NCT04695990

Brief Summary

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a Chinese population with heart failure after myocardial infarction. The objective is to observe the efficacy and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 6, 2021

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

November 29, 2020

Last Update Submit

January 4, 2021

Conditions

Heart FailureMyocardial Infarction

Keywords

Wenyang Huoxue decoction

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular events

    The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization

    One months to 1 year after drug intervention

Secondary Outcomes (2)

  • Main observation indicators

    Into the group day 1, week 4, week 8, week 12

  • Secondary observation index

    Into the group day 1, week 4, week 8, week 12

Study Arms (2)

Experimental group

EXPERIMENTAL

On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given Wenyang Huoxue Decoction, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Drug: Wenyang Huoxue Decoction

Control group

PLACEBO COMPARATOR

On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given placebo, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Drug: Wenyang Huoxue placebo

Interventions

Wenyang Huoxue DecoctionDRUG

Wenyang Huoxue granules

Also known as: WYHX
Experimental group
Wenyang Huoxue placeboDRUG

Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.

Also known as: WYHX placebo
Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • A history of acute myocardial infarction;
  • Cardiac function grade II-IV;
  • LVEF 40% or less; NT-proBNP level ≥ 450 pg/mL; -All men and women can sign the informed consent form.-

You may not qualify if:

  • Coronary artery bypass grafting was performed within 12 weeks.
  • Undergo or possibly undergo cardiac resynchronization therapy;
  • Primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction;
  • Having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control;
  • Serum creatinine \> 194.5 mol/L or serum potassium \> 5.5mmol /L;
  • The level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit ;
  • Abnormal blood pressure control, systolic blood pressure exceeding 180mmHg or diastolic blood pressure exceeding 110mmHg;
  • Pregnancy or lactation;
  • Known or suspected allergy to research drugs;
  • To receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

    PMID: 29386200RESULT

  • Hildebrandt P. Systolic and nonsystolic heart failure: equally serious threats. JAMA. 2006 Nov 8;296(18):2259-60. doi: 10.1001/jama.296.18.2259. No abstract available.

    PMID: 17090774RESULT

  • Gheorghiade M, Bonow RO. Chronic heart failure in the United States: a manifestation of coronary artery disease. Circulation. 1998 Jan 27;97(3):282-9. doi: 10.1161/01.cir.97.3.282. No abstract available.

    PMID: 9462531RESULT

  • Gerber Y, Melton LJ 3rd, Weston SA, Roger VL. Association between myocardial infarction and fractures: an emerging phenomenon. Circulation. 2011 Jul 19;124(3):297-303. doi: 10.1161/CIRCULATIONAHA.110.007195. Epub 2011 Jun 27.

    PMID: 21709062RESULT

  • Ezekowitz JA, Kaul P, Bakal JA, Armstrong PW, Welsh RC, McAlister FA. Declining in-hospital mortality and increasing heart failure incidence in elderly patients with first myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):13-20. doi: 10.1016/j.jacc.2008.08.067.

    PMID: 19118718RESULT

MeSH Terms

Conditions

Heart FailureMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jun Li, MD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Jun Li, MD

CONTACT

13051458913gamyylj@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 29, 2020

First Posted

January 6, 2021

Study Start

January 15, 2021

Primary Completion

March 1, 2022

Study Completion

December 30, 2022

Last Updated

January 6, 2021

Record last verified: 2020-12