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NCT Number: NCT02135835

A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure

The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.

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Key information

Conditions

Acute Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

An Hui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Acute Heart Failure according to Guidelines for the diagnosis and treatment of acute heart failure 2010 of Chinese Medical Association(Participants whose Heart function grade of NYHA is Ⅲ～Ⅳ).
  • LVEF≤40%.
  • NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL.
  • Ages 18-80, male or female.
  • All participants signed the informed consent.

Exclusion criteria

  • Participants with abnormal liver function (ALT, AST≥3 times of upper limit of normal) or abnormal kidney function( Cr≥1.5 times of upper limit of normal or Cr >3.0 mg/dl (> 265 µmol/L)).
  • SBP ≥ 150mmHg.
  • Participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
  • Participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
  • Participants with advanced cancer.
  • Breastfeeding, pregnant and potentially fertile women participant.
  • Participants with insanity.
  • Known allergies with Shenfu Zhusheye or its ingredients in the past.
  • Participants who have taken part in other clinical trials in last month.
  • Participants who abuse alcohol or other drugs in last year.
  • Participants who are not suitable for clinical trial under doctors' consideration.

Treatment and study plan

Shenfu Zhusheye

Drug

5% glucose injection

Drug

Primary outcomes

  1. Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.

    Time frame: 0, 7 days

Secondary outcomes

  1. Decrease rate in NT-proBNP compared to pre-treatment.

    Time frame: 0, 7 days.

  2. Decrease value in NT-proBNP compared to pre-treatment.

    Time frame: 0, 7 days.

  3. Likert rating scale of Dyspnoea.

    Time frame: 0, 7 days.

  4. The results of Transthoracic Doppler-echocardiography .

    Time frame: 0, 7 days.

    Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography.

  5. Heart function grade of NYHA.

    Time frame: 0, 7 days.

  6. Composite endpoints.

    Time frame: Composite endpoints will be assessed during medication period and 28 days after medication.

    Composite endpoints were defined as death, cardiac arrest with resuscitation, readmission for heart failure, worsening heart failure with an intravenous pharmacologic agent for more than 4 hours, stroke or cases where the patient ceased active treatments because of worsening heart failure.

  7. Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram.

    Time frame: Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.

Sponsors and collaborators

Lead sponsor

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 12, 2014
Registry last updated
Mar 1, 2018

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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