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Completed

NCT Number: NCT02742909

Acute Effects of rhBNP in Patients With PH 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shenjing Hospital

Shenyang, Liaoning, 110004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

rhBNP

Drug

rhBNP was administered as a continuous infusion for 24 hours before or after placebo

Other names: Recombinant Human Brain Natriuretic Peptide

Placebo

Drug

normal saline as a placebo was administered as a continuous infusion for 24 hours

Other names: normal saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Li Zhao

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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