Acute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease

September 29, 2019 updated by: LI ZHAO, Li Zhao

Acute Effect of Recombinant Human Brain Natriuretic Peptide in Patients With Pulmonary Hypertension Associated With Acute Exacerbation of Chronic Pulmonary Disease

To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by Swan- Ganz catheter.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pulmonary hypertension (PH) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients. Currently, no effective drugs treatment was used in patients with pulmonary hypertension due to acute exacerbation of lung disease. Recombinant Human Brain Natriuretic Peptide (rhBNP)was approved in 2001 for use in patients with acute heart failure on the basis of studies showing a reduction in pulmonary-capillary wedge pressure(PCWP) and pulmonary arterial pressure (PAP) and improvement cardiac output (CO) . Thus, the study was designed to administer rhBNP as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by Swan- Ganz catheter. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shenjing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age>18 years old, male or female;
  2. in acute exacerbation period and with a history of chronic respiratory diseases;
  3. cardiac ultrasound showed a pulmonary hypertension ≥50mmHg;
  4. grade II or WHO grade of heart function;
  5. signed informed consent.

Exclusion Criteria:

  1. pulmonary hypertension not associated with chronic lung disease;
  2. Acute or severe chronic left heart failure;
  3. severe respiratory failure during receipt of non-invasive or invasive ventilator therapy;
  4. mPAP≤25mmHg or pulmonary capillary wedge pressure (PCWP) ≥15mmHg at rest as assessed by Swan- Ganz catheter;
  5. a high risk of hypotension (systolic pressure <100 mmHg or 110 mmHg with the use of intravenous nitroglycerin);
  6. Uncontrolled arterial hypertension;
  7. acute coronary syndrome;
  8. Severe left ventricular hypertrophy;
  9. Congenital or acquired valvular or myocardial disease;
  10. end-stage renal disease during receipt of renal replacement therapy;
  11. clinically significant anemia;
  12. other contraindications for vasodilators;
  13. treatment with dobutamine (at a dose ≥5 μg per kilogram of body weight per minute);
  14. treatment with milrinone or levosimendan within the previous 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: rhBNP
the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received rhBNP.
Drug: rhBNP
rhBNP was administered as a continuous infusion for 24 hours before or after placebo
Other Names:
  • Recombinant Human Brain Natriuretic Peptide
Placebo Comparator: Placebo
the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received placebo.
Drug: placebo
normal saline as a placebo was administered as a continuous infusion for 24 hours
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter
Time Frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter
Time Frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter
Time Frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter
Time Frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
cardiac output(CO) measured by Swan-Ganz catheter
Time Frame: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
heat rate (HR)
Time Frame: baseline and 30 hours
baseline and 30 hours
respiratory rate(RR)
Time Frame: baseline and 30 hours
baseline and 30 hours
blood pressure(BP)
Time Frame: baseline and 30 hours
baseline and 30 hours
blood oxygen saturation(SPO2)
Time Frame: baseline and 30 hours
baseline and 30 hours
Brog classification
Time Frame: baseline and 30 hours
this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree.
baseline and 30 hours
Brain Natriuretic Peptide(BNP) in blood
Time Frame: baseline and 30 hours
baseline and 30 hours
N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood
Time Frame: baseline and 30 hours
baseline and 30 hours
Potential of Hydrogen(PH) in artery blood gas analysis
Time Frame: baseline and 30 hours
baseline and 30 hours
arterial partial pressure of oxygen(PaO2)
Time Frame: baseline and 30 hours
baseline and 30 hours
arterial partial pressure of carbon dioxide (PaCO2)
Time Frame: baseline and 30 hours
baseline and 30 hours
oxygenation index in artery blood gas analysis
Time Frame: baseline and 30 hours
baseline and 30 hours
alveolar-arterial oxygen difference in artery blood gas analysis
Time Frame: baseline and 30 hours
baseline and 30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Li Zhao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LI ZHAO, DOCTOR, SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJHX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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