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NCT Number: NCT06699407

Qishenyiqi for Ventricular Remodeling After Myocardial Infarction

The effects of Qishenyiqi dripping pill on cardiac remodeling in patients with chronic stable heart failure have not been reported. This project aims to clarify the efficacy and safety of Qishenyiqi in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure after myocardial infarction were selected and randomly divided into two groups: the treatment group was treated with Qishenyiqi dripping pills; The control group was given placebo treatment. After 12 months of follow-up, the effects of Qishenyiqi on cardiac remodeling and function and cardiovascular adverse events were evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Panpan Hao, Jinan, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) The history of acute myocardial infarction exceeds 3 months;
  • 2) Symptoms and signs of heart failure have been stable for more than one month;
  • 3) 18 years old or more;
  • 4) NYHA cardiac function classified as grade II~IV;
  • 5) LVEF≤40%;
  • 6) NT-proBNP≥450pg/ml;
  • 7) All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion criteria

  • 1) Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
  • 2) Planned to undergo cardiac surgery within 12 months;
  • 3) Mechanical complications of myocardial infarction;
  • 4) Pregnant or nursing, or having the intention to give birth within one year;
  • 5) Patients who participated in clinical research of other drugs within 3 months before being selected;
  • 6) Patients with poor sound transmission windows are examined by transthoracic ultrasound.

Treatment and study plan

Qishenyiqi dripping pills

Drug

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Placebo

Drug

Placebo, 1 bag once, three times a day, 12 months

Primary outcomes

  1. LVEDVI=LVEDV/BSA

    Time frame: From baseline to 12 months after follow-up

    Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Panpan Hao

CONTACT

[email protected]

18560086593

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Efficacy and Safety of Qishenyiqi Dripping Pills in Patients With Ventricular Remodeling and Chronic Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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