Diastolic DysfunctionNCT04128735
Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
An observational study of Diastolic Dysfunction and Morbid Obesity, run by Mahidol University at 1 site in Thailand.
Trial summary
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diastolic Dysfunction, Morbid Obesity
- How many people
- 116 participants
- Where
- 1 siteThailand
- Study dates
- 30 Oct 2019to 28 Feb 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Criteria for patient enrolled to bariatric surgery in Siriraj hospital * BMI more than 40 kg/m2 * BMI more than 35 kg/m2 with hypertension, type 2 diabetes, hyperlipidemia, obstructive sleep apnea, chronic arthritis * age between 18 - 70 years old
Who may be able to join
- Every patient scheduled for bariatric surgery in Siriraj hospital
Who cannot join
- Patient refusal
- patient with contraindication for transesophageal echocardiogram such as preexisting esophageal disease, recent upper gastrointestinal bleeding, coagulopathy, etc. (according to American society of Echocardiography guideline)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
Read the detailed description
Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities. Many cardiac problems were previously reported including left ventricular hypertrophy, right and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in normal left ventricular systolic function and can lead to diastolic heart failure postoperatively.
Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this problem may be underestimated. Transesophageal echocardiogram provides better cardiac view, but requires sedation during procedure. So, it is not practical for out-patient setting. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
- Conditions
- Diastolic Dysfunction, Morbid Obesity
- Keywords
- Diastolic dysfunction, Morbid Obesity, Bariatric surgery
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diastolic dysfunction
Prevalence of diastolic dysfunction according to American society of echocardiography definition
Measured: during surgery
Secondary outcomes (5)
Prevalence of other cardiac abnormalities
Number of patients with other cardiac abnormalities, both structural and functional abnormalities
Measured: during surgery
Incidence of cardiac adverse events
Number of patients with cardiac adverse event: myocardial ischemia, pulmonary edema
Measured: within 24 hours after surgery
Incidence of pulmonary adverse events
Number of patients experienced aspiration, desaturation, re-intubation
Measured: within 24 hours after surgery
Incidence of oral and airway trauma
Number of patients with new loose teeth, sore throat, difficult to swallow, hoarseness of voice
Measured: within 24 hours after surgery
Length of hospital stay
duration of hospital stay
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Oct 2019
- Primary completion30 Dec 2022
- Study completion28 Feb 2023
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 Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aphichat Suphathamwit, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128735
- Sponsor's protocol ID
- 2018_2
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2019
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabrera Schulmeyer MC, Arriaza N. Good prognostic value of the intraoperative tissue Doppler-derived index E/e' after non-cardiac surgery. Minerva Anestesiol. 2012 Sep;78(9):1013-8. Epub 2012 Jun 14.
PubMed 22699700Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available.
PubMed 23998692Aljaroudi W, Alraies MC, Halley C, Rodriguez L, Grimm RA, Thomas JD, Jaber WA. Impact of progression of diastolic dysfunction on mortality in patients with normal ejection fraction. Circulation. 2012 Feb 14;125(6):782-8. doi: 10.1161/CIRCULATIONAHA.111.066423. Epub 2012 Jan 18.
PubMed 22261198
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Diastolic Dysfunction in Morbidly Obese Patients Undergo Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04128735
- Acronym / sponsor ID
- 2018_2
- Conditions
- Diastolic Dysfunction, Morbid Obesity
- Keywords
- Diastolic dysfunction, Morbid Obesity, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Oct 2019 (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.
Morbidly obese patients are at risk for diastolic cardiac dysfunction, which can lead to adverse event, such as, diastolic heart failure postoperatively. Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge, therefore the prevalence of this problem may be underestimated. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
Detailed description
Morbidly obese patients are at risk for both respiratory and cardiovascular abnormalities. Many cardiac problems were previously reported including left ventricular hypertrophy, right and left ventricular systolic dysfunction etc. Diastolic cardiac dysfunction can be found in normal left ventricular systolic function and can lead to diastolic heart failure postoperatively.
Preoperative screening by transthoracic echocardiogram is difficult due to anatomical challenge (thick chest wall, narrowing of inter-rib space), therefore the prevalence of this problem may be underestimated. Transesophageal echocardiogram provides better cardiac view, but requires sedation during procedure. So, it is not practical for out-patient setting. The investigator would like to perform transesophageal echocardiogram in this group of patients after anesthesia induction to demonstrate the true prevalence of this syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Criteria for patient enrolled to bariatric surgery in Siriraj hospital * BMI more than 40 kg/m2 * BMI more than 35 kg/m2 with hypertension, type 2 diabetes, hyperlipidemia, obstructive sleep apnea, chronic arthritis * age between 18 - 70 years old
Key inclusion criteria (1 listed)
- Every patient scheduled for bariatric surgery in Siriraj hospital
Key exclusion criteria (2 listed)
- Patient refusal
- patient with contraindication for transesophageal echocardiogram such as preexisting esophageal disease, recent upper gastrointestinal bleeding, coagulopathy, etc. (according to American society of Echocardiography guideline)
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
Prevalence of diastolic dysfunction
Time frame: during surgery
Prevalence of diastolic dysfunction according to American society of echocardiography definition
5 secondary outcomes
Prevalence of other cardiac abnormalities
Time frame: during surgery
Incidence of cardiac adverse events
Time frame: within 24 hours after surgery
Incidence of pulmonary adverse events
Time frame: within 24 hours after surgery
Incidence of oral and airway trauma
Time frame: within 24 hours after surgery
Length of hospital stay
Time frame: up to 5 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 16 Mar 2023.
- Background: PubMed 22699700Cabrera Schulmeyer MC, Arriaza N. Good prognostic value of the intraoperative tissue Doppler-derived index E/e' after non-cardiac surgery. Minerva Anestesiol. 2012 Sep;78(9):1013-8. Epub 2012 Jun 14.
- Background: PubMed 23998692Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available.
- Results publication: PubMed 22261198Aljaroudi W, Alraies MC, Halley C, Rodriguez L, Grimm RA, Thomas JD, Jaber WA. Impact of progression of diastolic dysfunction on mortality in patients with normal ejection fraction. Circulation. 2012 Feb 14;125(6):782-8. doi: 10.1161/CIRCULATIONAHA.111.066423. Epub 2012 Jan 18.
- Individual participant dataSharing planned: No
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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.
Aphichat Suphathamwit, M.D. principal investigator
Mahidol 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 Diastolic Dysfunction and Morbid Obesity, run by Mahidol University at 1 site in Thailand.
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 2 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 16 Mar 2023. 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 Thailand. 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?
Prevalence of diastolic dysfunction (time frame: during surgery). 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 NCT04128735, 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 16 Mar 2023.