Diastolic DysfunctionNCT03534440
Assessment of Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery
An observational study of Diastolic Dysfunction and Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diastolic Dysfunction, Heart Failure, Aneurysm Aortic
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2018to 30 Jan 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for a Thoracic Endovascular Aortic Repair
Who may be able to join
- scheduled TEVAR
- >60 years old
Who cannot join
- Atrial fibrillation or other non-sinus rhythms
- Atrioventricular blocks
- Heart rate change more than 25% postoperatively
- Not adequate transthoracic view
- Postoperative shock
- Sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Left Ventricle Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery as an Early Indicator of Cardiac Failure. Observational Study
Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period.
Read the detailed description
Patients undergoing TEVAR surgery are a high risk group of developing perioperative cardiovascular complications.
Left ventricle diastolic dysfunction is common in this group of patients because of the prevalence of risk factors: > 60 years old, hypertension, smoking history and diabetes.
Because of many predisposing factors that occur during the surgery: stress respond, fluid shifts, anaesthesia and mechanical ventilation. Deterioration of the diastolic function is likely to occur in perioperative period
In this study, the investigators will evaluate change in left ventricle diastolic function as a marker for early detection of a myocardial failure in patients scheduled for an elective TEVAR surgery. The examination will be performed preoperatively, shortly after the surgery and 24 hours after the surgery.
Aim: The aim of the study is to evaluate the diastolic function of left ventricle in perioperative period after high risk surgery. This may provide a valuable information in preoperative risk stratification and postoperative therapy guidance.
- Conditions
- Diastolic Dysfunction, Heart Failure, Aneurysm Aortic
- Keywords
- Diastolic Dysfunction, Anesthesia, Preoperative assessment, Postoperative care, TEVAR
- Medical subject headings
- Heart Failure, Aortic Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricle diastolic function in time
Echocardiographic assessment of change in left ventricle diastolic function repeated in time intervals:
Baseline before the surgery, 2 and 24 hours after the surgery
Measured: Baseline, 2 hours and 24 hours
Secondary outcomes (9)
Change in biochemistry markers: troponins
Assessment of change in level of troponins. Baseline before the surgery, 2 and 24 hours after the surgery
Measured: Baseline, 2 hours and 24 hours
Change in biochemistry markers: brain natriuretic peptide
Assessment of change in level of brain natriuretic peptide. Baseline before the surgery, 2 and 24 hours after the surgery
Measured: Baseline, 2 hours and 24 hours
Change in left ventricle systolic function
Echocardiographic assessment of change in left ventricle systolic function repeated in time intervals:
Baseline before the surgery, 2 and 24 hours after the surgery
Measured: Baseline, 2 hours and 24 hours
Hemodynamic parameters: Heart rate
Heart rate during echocardiography evaluation.
Measured: Baseline, 2 hours and 24 hours
Hemodynamic parameters: Systolic and diastolic pressure
Systolic and diastolic pressure measurements during echocardiography evaluation. Record vasopressors requirement.
Measured: Baseline, 2 hours and 24 hours
Fluid balance
Monitoring of diuresis hourly, fluid losses and fluids intake
Measured: 72 hours
Kidney function
Monitoring of glomerular filtration rate and requirement for a dialysis daily
Measured: 72 hours
Length of stay in hospital
Documentation of length of stay in hospital since the surgery
Measured: up to 14 days
Mortality
Documentation of in-hospital mortality and 30 days mortality
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jul 2018
- Primary completion19 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Zawadka, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534440
- Sponsor's protocol ID
- DD-TEVAR-2018
- Status last verified
- Jul 2020
- First submitted
- 15 Apr 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Ventricle Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery as an Early Indicator of Cardiac Failure. Observational Study
- ClinicalTrials.gov ID
- NCT03534440
- Acronym / sponsor ID
- DD-TEVAR-2018
- Conditions
- Diastolic Dysfunction, Heart Failure, Aneurysm Aortic
- Keywords
- Diastolic Dysfunction, Anesthesia, Preoperative assessment, Postoperative care, TEVAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 23 May 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.
Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period.
Detailed description
Patients undergoing TEVAR surgery are a high risk group of developing perioperative cardiovascular complications.
Left ventricle diastolic dysfunction is common in this group of patients because of the prevalence of risk factors: > 60 years old, hypertension, smoking history and diabetes.
Because of many predisposing factors that occur during the surgery: stress respond, fluid shifts, anaesthesia and mechanical ventilation. Deterioration of the diastolic function is likely to occur in perioperative period
In this study, the investigators will evaluate change in left ventricle diastolic function as a marker for early detection of a myocardial failure in patients scheduled for an elective TEVAR surgery. The examination will be performed preoperatively, shortly after the surgery and 24 hours after the surgery.
Aim: The aim of the study is to evaluate the diastolic function of left ventricle in perioperative period after high risk surgery. This may provide a valuable information in preoperative risk stratification and postoperative therapy guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a Thoracic Endovascular Aortic Repair
Key inclusion criteria (2 listed)
- scheduled TEVAR
- >60 years old
Key exclusion criteria (6 listed)
- Atrial fibrillation or other non-sinus rhythms
- Atrioventricular blocks
- Heart rate change more than 25% postoperatively
- Not adequate transthoracic view
- Postoperative shock
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
Change in left ventricle diastolic function in time
Time frame: Baseline, 2 hours and 24 hours
Echocardiographic assessment of change in left ventricle diastolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery
9 secondary outcomes
Change in biochemistry markers: troponins
Time frame: Baseline, 2 hours and 24 hours
Change in biochemistry markers: brain natriuretic peptide
Time frame: Baseline, 2 hours and 24 hours
Change in left ventricle systolic function
Time frame: Baseline, 2 hours and 24 hours
Hemodynamic parameters: Heart rate
Time frame: Baseline, 2 hours and 24 hours
Hemodynamic parameters: Systolic and diastolic pressure
Time frame: Baseline, 2 hours and 24 hours
Fluid balance
Time frame: 72 hours
Kidney function
Time frame: 72 hours
Length of stay in hospital
Time frame: up to 14 days
Mortality
Time frame: up to 30 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 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Diastolic Dysfunction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
Optimised Cardiovascular and Renal Protection in Patients With Chronic Kidney Disease and Cardiovascular Disease
Chronic Kidney Disease, Heart Failure With Preserved Ejection Fraction (HFPEF)
Not yet recruitingObservational study
Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function
Obesity, Diastolic Dysfunction
Active, not recruitingObservational study
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
HIV Infections
Not yet recruiting
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Hypertension, Left Ventricular Diastolic Dysfunction
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure, run by Medical University of Warsaw at 1 site in Poland.
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 2 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 7 Jul 2020. 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 Poland. 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?
Change in left ventricle diastolic function in time (time frame: Baseline, 2 hours and 24 hours). 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 7 Jul 2020.