Pulmonary HypertensionPhase 4NCT02742909

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

A Phase 4 study testing rhBNP in people with Pulmonary Hypertension, run by LI ZHAO at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Hypertension
What is being tested?: rhBNP
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 1 siteChina
Study dates: Dec 2015to Dec 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shenjing Hospital
Shenyang, Liaoning, 110004

Other trials in China

About this study

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

Read the 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
Being tested: rhBNP, placebo
Medical subject headings: Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhBNPDrug
Also called Recombinant Human Brain Natriuretic Peptide
rhBNP was administered as a continuous infusion for 24 hours before or after placebo
placeboDrug
Also called normal saline
normal saline as a placebo was administered as a continuous infusion for 24 hours

Study groups in NCT02742909
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter
we are going to record a change
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours

Secondary outcomes (12)

heat rate (HR)
Measured: baseline and 30 hours
respiratory rate(RR)
Measured: baseline and 30 hours
blood pressure(BP)
Measured: baseline and 30 hours
blood oxygen saturation(SPO2)
Measured: baseline and 30 hours
Brog classification
this is a classification table for patient' s feeling of fatigue and dyspnea. from 1 to 10 degree.
Measured: baseline and 30 hours
Brain Natriuretic Peptide(BNP) in blood
Measured: baseline and 30 hours
N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood
Measured: baseline and 30 hours
Potential of Hydrogen(PH) in artery blood gas analysis
Measured: baseline and 30 hours
arterial partial pressure of oxygen(PaO2)
Measured: baseline and 30 hours
arterial partial pressure of carbon dioxide (PaCO2)
Measured: baseline and 30 hours
oxygenation index in artery blood gas analysis
Measured: baseline and 30 hours
alveolar-arterial oxygen difference in artery blood gas analysis
Measured: baseline and 30 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Dec 2018

First posted19 Apr 2016 (estimated)
Study startDec 2015
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02742909
Sponsor's protocol ID: SJHX-001
Status last verified: Sep 2019
First submitted: 9 Oct 2015
Last updated: 1 Oct 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

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.
PubMed 24855320
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.
PubMed 21732835
Mingguang Huang,Yingjun Dong. Clinical observation on rhBNP in treating patients with pulmonary artery hypertension. Shanxi Medical Journal,2011,40(6):545-546.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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All Pulmonary Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Effect of Recombinant Human Brain Natriuretic Peptide in Patients With Pulmonary Hypertension Associated With Acute Exacerbation of Chronic Pulmonary Disease
ClinicalTrials.gov ID: NCT02742909
Acronym / sponsor ID: SJHX-001
Conditions: Pulmonary Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: LI ZHAOUniversity, hospital or other
Study start: Dec 2015
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 19 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
rhBNP	Active comparator	Drug: rhBNPthe 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.
Placebo	Placebo comparator	Drug: placebothe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rhBNPAlso: Recombinant Human Brain Natriuretic PeptiderhBNP was administered as a continuous infusion for 24 hours before or after placebo	Drug	rhBNP
placeboAlso: normal salinenormal saline as a placebo was administered as a continuous infusion for 24 hours	Drug	Placebo

Primary outcome

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
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
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
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
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

12 secondary outcomes

heat rate (HR)
Time frame: baseline and 30 hours
respiratory rate(RR)
Time frame: baseline and 30 hours
blood pressure(BP)
Time frame: baseline and 30 hours
blood oxygen saturation(SPO2)
Time frame: baseline and 30 hours
Brog classification
Time frame: baseline and 30 hours
Brain Natriuretic Peptide(BNP) in blood
Time frame: baseline and 30 hours
N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood
Time frame: baseline and 30 hours
Potential of Hydrogen(PH) in artery blood gas analysis
Time frame: baseline and 30 hours
arterial partial pressure of oxygen(PaO2)
Time frame: baseline and 30 hours
arterial partial pressure of carbon dioxide (PaCO2)
Time frame: baseline and 30 hours
oxygenation index in artery blood gas analysis
Time frame: baseline and 30 hours
alveolar-arterial oxygen difference in artery blood gas analysis
Time frame: baseline and 30 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Background: PubMed 24855320Haeck 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.
Background: PubMed 21732835O'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.
BackgroundMingguang Huang,Yingjun Dong. Clinical observation on rhBNP in treating patients with pulmonary artery hypertension. Shanxi Medical Journal,2011,40(6):545-546.
Individual participant dataSharing planned: Yes

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

LI ZHAO, DOCTOR principal investigator

SHENJING HOSPTIAL OF CHINA MEDICAL UNIVERSITY

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rhBNP in people with Pulmonary Hypertension, run by LI ZHAO at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742909, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.