Back to resultsAcute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rhBNP
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension
Eligibility Criteria
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.
Sites / Locations
- Shenjing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
rhBNP
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter
we are going to record a change
pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter
we are going to record a change
mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter
we are going to record a change
pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter
we are going to record a change
cardiac output(CO) measured by Swan-Ganz catheter
we are going to record a change
Secondary Outcome Measures
heat rate (HR)
respiratory rate(RR)
blood pressure(BP)
blood oxygen saturation(SPO2)
Brog classification
this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree.
Brain Natriuretic Peptide(BNP) in blood
N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood
Potential of Hydrogen(PH) in artery blood gas analysis
arterial partial pressure of oxygen(PaO2)
arterial partial pressure of carbon dioxide (PaCO2)
oxygenation index in artery blood gas analysis
alveolar-arterial oxygen difference in artery blood gas analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02742909
Brief Title
Acute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease
Official Title
Acute Effect of Recombinant Human Brain Natriuretic Peptide in Patients With Pulmonary Hypertension Associated With Acute Exacerbation of Chronic Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LI ZHAO
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhBNP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
rhBNP
Other Intervention Name(s)
Recombinant Human Brain Natriuretic Peptide
Intervention Description
rhBNP was administered as a continuous infusion for 24 hours before or after placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline
Intervention Description
normal saline as a placebo was administered as a continuous infusion for 24 hours
Primary Outcome Measure Information:
Title
pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter
Description
we are going to record a change
Time Frame
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Title
pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter
Description
we are going to record a change
Time Frame
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Title
mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter
Description
we are going to record a change
Time Frame
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Title
pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter
Description
we are going to record a change
Time Frame
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Title
cardiac output(CO) measured by Swan-Ganz catheter
Description
we are going to record a change
Time Frame
baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Secondary Outcome Measure Information:
Title
heat rate (HR)
Time Frame
baseline and 30 hours
Title
respiratory rate(RR)
Time Frame
baseline and 30 hours
Title
blood pressure(BP)
Time Frame
baseline and 30 hours
Title
blood oxygen saturation(SPO2)
Time Frame
baseline and 30 hours
Title
Brog classification
Description
this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree.
Time Frame
baseline and 30 hours
Title
Brain Natriuretic Peptide(BNP) in blood
Time Frame
baseline and 30 hours
Title
N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood
Time Frame
baseline and 30 hours
Title
Potential of Hydrogen(PH) in artery blood gas analysis
Time Frame
baseline and 30 hours
Title
arterial partial pressure of oxygen(PaO2)
Time Frame
baseline and 30 hours
Title
arterial partial pressure of carbon dioxide (PaCO2)
Time Frame
baseline and 30 hours
Title
oxygenation index in artery blood gas analysis
Time Frame
baseline and 30 hours
Title
alveolar-arterial oxygen difference in artery blood gas analysis
Time Frame
baseline and 30 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LI ZHAO, DOCTOR
Organizational Affiliation
SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
24855320
Citation
Haeck ML, Vliegen HW. Diagnosis and treatment of pulmonary hypertension. Heart. 2015 Feb;101(4):311-9. doi: 10.1136/heartjnl-2011-301386. Epub 2014 May 22. No abstract available.
Results Reference
background
PubMed Identifier
21732835
Citation
O'Connor CM, Starling RC, Hernandez AF, Armstrong PW, Dickstein K, Hasselblad V, Heizer GM, Komajda M, Massie BM, McMurray JJ, Nieminen MS, Reist CJ, Rouleau JL, Swedberg K, Adams KF Jr, Anker SD, Atar D, Battler A, Botero R, Bohidar NR, Butler J, Clausell N, Corbalan R, Costanzo MR, Dahlstrom U, Deckelbaum LI, Diaz R, Dunlap ME, Ezekowitz JA, Feldman D, Felker GM, Fonarow GC, Gennevois D, Gottlieb SS, Hill JA, Hollander JE, Howlett JG, Hudson MP, Kociol RD, Krum H, Laucevicius A, Levy WC, Mendez GF, Metra M, Mittal S, Oh BH, Pereira NL, Ponikowski P, Tang WH, Tanomsup S, Teerlink JR, Triposkiadis F, Troughton RW, Voors AA, Whellan DJ, Zannad F, Califf RM. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med. 2011 Jul 7;365(1):32-43. doi: 10.1056/NEJMoa1100171. Erratum In: N Engl J Med. 2011 Aug 25;365(8):773. Wilson, W H [corrected to Tang, W H W].
Results Reference
background
Citation
Mingguang Huang,Yingjun Dong. Clinical observation on rhBNP in treating patients with pulmonary artery hypertension. Shanxi Medical Journal,2011,40(6):545-546.
Results Reference
background
Learn more about this trial
Acute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease
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