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

NCT02742909 | Completed Phase 4 DMC

• 1 other identifier: SJHX-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (12)

• heat rate (HR)

  baseline and 30 hours

• respiratory rate(RR)

  baseline and 30 hours

• blood pressure(BP)

  baseline and 30 hours

• blood oxygen saturation(SPO2)

  baseline and 30 hours

• Brog classification

  baseline and 30 hours

Study Arms (2)

rhBNP

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

rhBNP DRUG

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

Also known as: Recombinant Human Brain Natriuretic Peptide

rhBNP

placebo DRUG

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

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LI ZHAO: lead

Study Sites (1)

Shenjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related 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. No abstract available.

  PMID: 24855320 BACKGROUND

• 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.

  PMID: 21732835 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• LI ZHAO, DOCTOR

  SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor /director

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: April 19, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)