Pulmonary HypertensionNCT03464591
Cardiac Speckle Tracking Myocardial Strain Balance
An observational study of Pulmonary Hypertension and Echocardiography, run by RenJi Hospital at 1 site in China.
Trial summary
The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Echocardiography
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 30 Dec 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From 2007 to date, 18-80 year old patients with mean pulmonary arterial pressure ≥25mmHg measured by right heart catheterization
Who may be able to join
- Diagnosed with pulmonary hypertension by right cardiac catheterization The patient is between 18-80 years of age The date of diagnosis was from 2007 to 2017
Who cannot join
- Cardiomyopathy Severe complications Pregnancy Atrial fibrillation, or other irregular heart rhythm Poor ultrasonic image quality
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai
Zhang Xueming, postgraduate, 18801967630, 18801967630@163.com
About this study
Official title: Cardiac Speckle Tracking Myocardial Strain Balance Method: a New Method to Evaluate the Effect of Pulmonary Hypertension on the Prognosis
The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.
Read the detailed description
Pulmonary hypertension is a fatal disease with progressive progressive vascular resistance that leads to the loss of right heart function. Right heart failure is the cause of death in most patients with end-stage pulmonary hypertension, and right heart function is also an important factor in determining the prognosis of patients.
Echocardiography speckle tracking technology is a noninvasive technique for evaluating global and local cardiac function by tracking myocardial ultrasonic spots through computer image analysis technology and quantifying myocardial deformation.
The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.
- Conditions
- Pulmonary Hypertension, Echocardiography
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome
death or time out
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Nov 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shen Jieyan, PhD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiaotong UniversityShen Xuedong, PhD, Study chair, RenJi Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464591
- Sponsor's protocol ID
- echocardiography of PH
- Status last verified
- Nov 2017
- First submitted
- 7 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Speckle Tracking Myocardial Strain Balance Method: a New Method to Evaluate the Effect of Pulmonary Hypertension on the Prognosis
- ClinicalTrials.gov ID
- NCT03464591
- Acronym / sponsor ID
- echocardiography of PH
- Conditions
- Pulmonary Hypertension, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 14 Mar 2018 (actual)
- 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.
The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.
Detailed description
Pulmonary hypertension is a fatal disease with progressive progressive vascular resistance that leads to the loss of right heart function. Right heart failure is the cause of death in most patients with end-stage pulmonary hypertension, and right heart function is also an important factor in determining the prognosis of patients.
Echocardiography speckle tracking technology is a noninvasive technique for evaluating global and local cardiac function by tracking myocardial ultrasonic spots through computer image analysis technology and quantifying myocardial deformation.
The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From 2007 to date, 18-80 year old patients with mean pulmonary arterial pressure ≥25mmHg measured by right heart catheterization
Key inclusion criteria (1 listed)
- Diagnosed with pulmonary hypertension by right cardiac catheterization The patient is between 18-80 years of age The date of diagnosis was from 2007 to 2017
Key exclusion criteria (1 listed)
- Cardiomyopathy Severe complications Pregnancy Atrial fibrillation, or other irregular heart rhythm Poor ultrasonic image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
outcome
Time frame: one year
death or time out
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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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.
Shen Jieyan, PhD study chair
RenJi Hospital, School of Medicine, Shanghai Jiaotong University
Shen Xuedong, PhD study chair
RenJi Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Echocardiography, run by RenJi Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shen Jieyan, PhD (13701864819, dr_jyshen@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome (time frame: one year). 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 27 Mar 2018.