Congestive Heart FailureHENCHFNCT04455477
Nesiritide for Ventilated Congestive Heart Failure
An observational study of Congestive Heart Failure and Mechanical Ventilation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Mechanical Ventilation, Using Nesiritide
- What is being tested?
- Nesiritide
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.
Who may be able to join
- Age≥18 years；
- Congestive Heart Failure;
- With mechanical ventilation；
- With hemodynamic monitoring devices;
- The physicians made the decision of using Nesiritide.
Who cannot join
- Unstable hemodynamic status；
- Severe renal dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Xuhui, Shanghai Municipality, 200032
Zhe Luo, +8613916127028, luo.zhe@zs-hospital.sh.cn
About this study
Official title: Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study
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.
- Conditions
- Congestive Heart Failure, Mechanical Ventilation, Using Nesiritide, Venous Return, Cardiac Function
- Being tested
- Nesiritide
- Keywords
- Congestive Heart Failure, Nesiritide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cardiac output
Changes of cardiac output measured by hemodynamical monitoring tools
Measured: Before and 30-min after using a standard dose of Nesiritide
Changes of systemic filling pressure
Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels.
Measured: Before and 30-min after using a standard dose of Nesiritide
Secondary outcomes (2)
Changes of cardiac function curve
Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve
Measured: Before and 30-min after using a standard dose of Nesiritide
Changes of venous return curve
Changes of venous return curve depicted by different PEEP setting
Measured: Before and 30-min after using a standard dose of Nesiritide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start14 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455477
- Sponsor's protocol ID
- B2020-056R
- Acronym
- HENCHF
- Status last verified
- Jun 2020
- First submitted
- 16 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our institution did not approve this.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04455477
- Acronym / sponsor ID
- HENCHF / B2020-056R
- Conditions
- Congestive Heart Failure, Mechanical Ventilation, Using Nesiritide, Venous Return, Cardiac Function
- Keywords
- Congestive Heart Failure, Nesiritide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.
Key inclusion criteria (5 listed)
- Age≥18 years；
- Congestive Heart Failure;
- With mechanical ventilation；
- With hemodynamic monitoring devices;
- The physicians made the decision of using Nesiritide.
Key exclusion criteria (2 listed)
- Unstable hemodynamic status；
- Severe renal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NesiritideThe attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled. | Drug | – |
Primary outcome
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
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.
2 secondary outcomes
Changes of cardiac function curve
Time frame: Before and 30-min after using a standard dose of Nesiritide
Changes of venous return curve
Time frame: Before and 30-min after using a standard dose of Nesiritide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No. Our institution did not approve this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Mechanical Ventilation, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Luo, MD (+8613916127028, luo.zhe@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cardiac output (time frame: Before and 30-min after using a standard dose of Nesiritide). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.