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Nesiritide for Ventilated Congestive Heart Failure (HENCHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04455477
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
The congestive heart failure is a common disease among patients who receive cardiac surgery and may lead to prolonged ventilation support. Nesiritide was a potential therapy for congestive heart failure. This study aimed to compare the Nesiritide induced hemodynamical status changes among congestive heart failure patients with invasive ventilation support.

Condition or disease Intervention/treatment
Congestive Heart Failure Mechanical Ventilation Using Nesiritide Venous Return Cardiac Function Drug: Nesiritide

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide


Intervention Details:
  • Drug: Nesiritide
    The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.


Primary Outcome Measures :
  1. Changes of cardiac output [ Time Frame: Before and 30-min after using a standard dose of Nesiritide ]
    Changes of cardiac output measured by hemodynamical monitoring tools

  2. Changes of systemic filling pressure [ Time Frame: Before and 30-min after using a standard dose of Nesiritide ]
    Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels.


Secondary Outcome Measures :
  1. Changes of cardiac function curve [ Time Frame: Before and 30-min after using a standard dose of Nesiritide ]
    Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve

  2. Changes of venous return curve [ Time Frame: Before and 30-min after using a standard dose of Nesiritide ]
    Changes of venous return curve depicted by different PEEP setting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.
Criteria

Inclusion Criteria:

  • Age≥18 years;
  • Congestive Heart Failure;
  • With mechanical ventilation;
  • With hemodynamic monitoring devices;
  • The physicians made the decision of using Nesiritide.

Exclusion Criteria:

  • Unstable hemodynamic status;
  • Severe renal dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455477


Contacts
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Contact: Zhe Luo, MD +8613916127028 luo.zhe@zs-hospital.sh.cn

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Xuhui, Shanghai, China, 200032
Contact: Zhe Luo    +8613916127028    luo.zhe@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04455477    
Other Study ID Numbers: B2020-056R
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Our institution did not approve this.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Congestive Heart Failure
Nesiritide
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs