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

NCT ID: NCT02742909

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-12-31

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

rhBNP

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

rhBNP

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Recombinant Human Brain Natriuretic Peptide; normal saline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LI ZHAO

OTHER

Sponsor Role: lead

Responsible Party

LI ZHAO

professor /director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

LI ZHAO, DOCTOR

Role: PRINCIPAL_INVESTIGATOR

SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY

Locations

Shenjing Hospital

Shenyang, Liaoning, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 24855320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21732835 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

SJHX-001

Identifier Type: -

Identifier Source: org_study_id