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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742909
• Other study ID #: SJHX-001
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• rhBNP
rhBNP was administered as a continuous infusion for 24 hours before or after placebo
• placebo
normal saline as a placebo was administered as a continuous infusion for 24 hours

Locations

Country	Name	City	State
China	Shenjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
LI ZHAO

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

Mingguang Huang,Yingjun Dong. Clinical observation on rhBNP in treating patients with pulmonary artery hypertension. Shanxi Medical Journal,2011,40(6):545-546.

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, Corbalán 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, Méndez 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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter	we are going to record a change	baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Primary	pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter	we are going to record a change	baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Primary	mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter	we are going to record a change	baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Primary	pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter	we are going to record a change	baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Primary	cardiac output(CO) measured by Swan-Ganz catheter	we are going to record a change	baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
Secondary	heat rate (HR)		baseline and 30 hours
Secondary	respiratory rate(RR)		baseline and 30 hours
Secondary	blood pressure(BP)		baseline and 30 hours
Secondary	blood oxygen saturation(SPO2)		baseline and 30 hours
Secondary	Brog classification	this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree.	baseline and 30 hours
Secondary	Brain Natriuretic Peptide(BNP) in blood		baseline and 30 hours
Secondary	N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood		baseline and 30 hours
Secondary	Potential of Hydrogen(PH) in artery blood gas analysis		baseline and 30 hours
Secondary	arterial partial pressure of oxygen(PaO2)		baseline and 30 hours
Secondary	arterial partial pressure of carbon dioxide (PaCO2)		baseline and 30 hours
Secondary	oxygenation index in artery blood gas analysis		baseline and 30 hours
Secondary	alveolar-arterial oxygen difference in artery blood gas analysis		baseline and 30 hours