Chronic Cor PulmonaleNCT02976324
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
A study testing external diaphragmatic pacemaker group in people with Chronic Cor Pulmonale, run by Zhang Xiangyu at 1 site in China.
Trial summary
This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Cor Pulmonale
- What is being tested?
- external diaphragmatic pacemaker group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Aug 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic cor pulmonale and admit to hospital
Who cannot join
- pneumothorax or mediastinal emphysema
- active tuberculosis
- install a cardiac pacemaker
- acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
- pregnancies
- end-stage patients (expected survival time less than 6 months)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.
Read the detailed description
Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.
- Conditions
- Chronic Cor Pulmonale
- Being tested
- external diaphragmatic pacemaker group
- Medical subject headings
- Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external diaphragmatic pacemaker groupDevice
9 counts per minute, with stimulate frequency 40 Hz
| Study group | Role | What they receive |
|---|---|---|
| external diaphragmatic pacemaker group | Experimental | use the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz Receives: Device: external diaphragmatic pacemaker group |
| control group | No intervention | No inervention, just receive conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary function
six miunte walk test
Measured: 10 days
Secondary outcomes (1)
MIP
MAX INSPIRATORY PRESSURE
Measured: 10 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cor PulmonaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Xiangyu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Xiangyu, Tongji University
- Investigators
- xiangyu zhang, doctor, Principal investigator, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976324
- Sponsor's protocol ID
- EDPCCP2016
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale
- ClinicalTrials.gov ID
- NCT02976324
- Acronym / sponsor ID
- EDPCCP2016
- Conditions
- Chronic Cor Pulmonale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zhang XiangyuUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Nov 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.
This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.
Detailed description
Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| external diaphragmatic pacemaker group | Experimental | Device: external diaphragmatic pacemaker groupuse the external diaphragmatic pacemakerI 9 counts per minute, with stimulate frequency 40 Hz |
| control group | No intervention | –No inervention, just receive conventional therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of chronic cor pulmonale and admit to hospital
Key exclusion criteria (6 listed)
- pneumothorax or mediastinal emphysema
- active tuberculosis
- install a cardiac pacemaker
- acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
- pregnancies
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 |
|---|---|---|
| external diaphragmatic pacemaker group9 counts per minute, with stimulate frequency 40 Hz | Device | external diaphragmatic pacemaker group |
Primary outcome
cardiopulmonary function
Time frame: 10 days
six miunte walk test
1 secondary outcome
MIP
Time frame: 10 DAYS
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 23 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
xiangyu zhang, doctor principal investigator
Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external diaphragmatic pacemaker group in people with Chronic Cor Pulmonale, run by Zhang Xiangyu 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 1 inclusion and 6 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 23 Oct 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
cardiopulmonary function (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2017.