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Early Management Strategies of Acute Heart Failure for Patients With NSTEMI (EMSAHF)

Primary Purpose

Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Regular management+Levosimendan
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Management

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients diagnosed with NSTEMI in outpatient service or admitted to hospital;
  2. Patients with an elevated NT-proBNP level;
  3. Patients sign the informed consent;

Exclusion Criteria:

  1. Patients with hypotension(systolic pressure<100mmHg), creatinine clearance rate<30ml/min or be allergic to levosimendan;
  2. Patients whose heart function grade of Killip are Level III~IV;
  3. Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor);
  4. Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis;
  5. Patients with serum potassium level<3.5mmol/L;
  6. Pregnant and lactating women;
  7. Patients participating in other relevant clinical studies.

Sites / Locations

  • Anhui Provincial Hospital
  • Beijing China-Japan Friendship Hospital
  • Affiliated Hospital of Xuzhou Medical University
  • Shengjing Hospital Affiliated to China Medical University
  • Shengli Oilfield Central Hospital
  • Binzhou People's Hospital
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Qilu Hospital of Shandong University
  • Tai'an Central Hospital
  • Weifang People's Hospital
  • Weihai Municipal Hospital
  • Yantaishan Hospital
  • Zibo Central Hospital
  • Qilu Hospital of Shandong University (Qingdao)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular Management

Regular management+Levosimendan

Arm Description

Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.

Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan.

Outcomes

Primary Outcome Measures

Blood NT-proBNP Level on 3 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 3 days after random allocation.
Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, and compare it with blood NT-proBNP level tested at first medical contact(baseline).

Secondary Outcome Measures

Acute Heart Failure Attack in Hospital
To record the number of times of acute heart failure attack in hospital, then analyse the statistic difference between two groups.
Major Adverse Cardiovascular and Cerebrovascular Events in Hospital
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, acute heart failure and stroke when patients are in hospital. Then the investigators analyse the statistic difference between two groups.
Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, rehospitalization because of acute heart failure and stroke on 6 months. Then the investigators analyse the statistic difference between two groups.
Security evaluation of levosimendan
Serious adverse reaction such as shock, malignant arrhythmia and so on.
Health Economics Analysis
To do health economics analysis using the data including inpatient days, hospitalization costs.
Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, then calculate the rate of patients whose plasma NT-proBNP level decreased at least 30%(compared with blood NT-proBNP level tested at first medical contact).

Full Information

First Posted
June 9, 2017
Last Updated
July 15, 2021
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03189901
Brief Title
Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
Acronym
EMSAHF
Official Title
Early Management Strategies of Acute Heart Failure for Patients With NSTEMI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
There are always poor outcomes in patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to use levosimendan may reduces the risk of heart failure and improve the outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Management, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular Management
Arm Type
No Intervention
Arm Description
Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline.
Arm Title
Regular management+Levosimendan
Arm Type
Experimental
Arm Description
Patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level who treated by regular strategy in guideline and levosimendan.
Intervention Type
Drug
Intervention Name(s)
Regular management+Levosimendan
Intervention Description
Patients are treated with regular management recommended in guidelines and levosimendan.
Primary Outcome Measure Information:
Title
Blood NT-proBNP Level on 3 Days after Random Allocation
Description
To test the blood NT-proBNP level in clinical labs 3 days after random allocation.
Time Frame
Venous blood is collected 3 days after random allocation. Blood NT-proBNP level is tested 1 month.
Title
Rate of Change from Baseline Blood NT-proBNP Level on 5 Days after Random Allocation
Description
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, and compare it with blood NT-proBNP level tested at first medical contact(baseline).
Time Frame
Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.
Secondary Outcome Measure Information:
Title
Acute Heart Failure Attack in Hospital
Description
To record the number of times of acute heart failure attack in hospital, then analyse the statistic difference between two groups.
Time Frame
The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Title
Major Adverse Cardiovascular and Cerebrovascular Events in Hospital
Description
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, acute heart failure and stroke when patients are in hospital. Then the investigators analyse the statistic difference between two groups.
Time Frame
The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Title
Major Adverse Cardiovascular and Cerebrovascular Events on 6 Months
Description
Major Adverse Cardiovascular Events include all-cause mortality, cardiac death, non-fatal myocardial re-infarction, rehospitalization because of acute heart failure and stroke on 6 months. Then the investigators analyse the statistic difference between two groups.
Time Frame
The data is collected on 6 months after patients discharged. Investigators analyse and summary the statistic difference between two groups through study completion.
Title
Security evaluation of levosimendan
Description
Serious adverse reaction such as shock, malignant arrhythmia and so on.
Time Frame
The data is collected during the time when levosimendan is used(an average of 24 hours). Investigators analyse and summary the statistic difference between two groups through study completion.
Title
Health Economics Analysis
Description
To do health economics analysis using the data including inpatient days, hospitalization costs.
Time Frame
The data is collected during the in hospital period(an average of 2 weeks). Investigators analyse and summary the statistic difference between two groups through study completion.
Title
Rate of Patients Whose Plasma NT-proBNP Level Changes at least 30% on 5 Days after Random Allocation
Description
To test the blood NT-proBNP level in clinical labs 5 days after random allocation, then calculate the rate of patients whose plasma NT-proBNP level decreased at least 30%(compared with blood NT-proBNP level tested at first medical contact).
Time Frame
Venous blood is collected at first medical contact and 5 days after random allocation, and blood NT-proBNP level is tested immediately after blood collection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with NSTEMI in outpatient service or admitted to hospital; Patients with an elevated NT-proBNP level; Patients sign the informed consent; Exclusion Criteria: Patients with hypotension(systolic pressure<100mmHg), creatinine clearance rate<30ml/min or be allergic to levosimendan; Patients whose heart function grade of Killip are Level III~IV; Patients suffering from hepatic failure, renal failure or other diseases which may shorten the lifetime to 6 months(for example tumor); Patients with valvular heart diseases influencing haemodynamics, hypertrophic or restricted cardiomyopathy, constrictive pericarditis, severe pulmonary hypertension or myocarditis; Patients with serum potassium level<3.5mmol/L; Pregnant and lactating women; Patients participating in other relevant clinical studies.
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Beijing China-Japan Friendship Hospital
City
Beijing
State/Province
Beijng
ZIP/Postal Code
100000
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Shengjing Hospital Affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandog
ZIP/Postal Code
257000
Country
China
Facility Name
Binzhou People's Hospital
City
Binzhou
State/Province
Shandong
ZIP/Postal Code
256600
Country
China
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Tai'an Central Hospital
City
Tai'an
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Facility Name
Weihai Municipal Hospital
City
Weihai
State/Province
Shandong
ZIP/Postal Code
264200
Country
China
Facility Name
Yantaishan Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Facility Name
Qilu Hospital of Shandong University (Qingdao)
City
Qingdao
ZIP/Postal Code
266000
Country
China

12. IPD Sharing Statement

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Early Management Strategies of Acute Heart Failure for Patients With NSTEMI

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