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

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ClinicalTrials.gov Identifier: NCT02742909
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
LI ZHAO, Shengjing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: rhBNP Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effect of Recombinant Human Brain Natriuretic Peptide in Patients With Pulmonary Hypertension Associated With Acute Exacerbation of Chronic Pulmonary Disease
Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: normal saline




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. heat rate (HR) [ Time Frame: baseline and 30 hours ]
  2. respiratory rate(RR) [ Time Frame: baseline and 30 hours ]
  3. blood pressure(BP) [ Time Frame: baseline and 30 hours ]
  4. blood oxygen saturation(SPO2) [ Time Frame: baseline and 30 hours ]
  5. 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.

  6. Brain Natriuretic Peptide(BNP) in blood [ Time Frame: baseline and 30 hours ]
  7. N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood [ Time Frame: baseline and 30 hours ]
  8. Potential of Hydrogen(PH) in artery blood gas analysis [ Time Frame: baseline and 30 hours ]
  9. arterial partial pressure of oxygen(PaO2) [ Time Frame: baseline and 30 hours ]
  10. arterial partial pressure of carbon dioxide (PaCO2) [ Time Frame: baseline and 30 hours ]
  11. oxygenation index in artery blood gas analysis [ Time Frame: baseline and 30 hours ]
  12. alveolar-arterial oxygen difference in artery blood gas analysis [ Time Frame: baseline and 30 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02742909


Locations
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China, Liaoning
Shenjing Hospital
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
LI ZHAO
Investigators
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Principal Investigator: LI ZHAO, DOCTOR SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY

Publications:
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Responsible Party: LI ZHAO, professor /director, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT02742909    
Other Study ID Numbers: SJHX-001
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs