Mitral Valve InsufficiencyDMRNCT02604745
Degenerative Mitral Regurgitation in Intermediate Risk Patients
An observational study of Mitral Valve Insufficiency and Mitral Regurgitation, run by Northwestern University at 1 site in United States.
Trial summary
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Regurgitation
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jan 2021
- 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 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with a history of mitral valve surgery for Degenerative Mitral Regurgitation (Type II).
Who may be able to join
- Prior surgery for degenerative mitral regurgitation (DMR) at Northwestern Memorial Hospital performed by a single surgeon.
- Male and female ≥ 65 years of age at time of index procedure.
- Mitral Valve surgery performed > 6 months and <36 months at the time of consent. Concomitant procedures at time of index procedure may include incidental CAB, MAZE and tricuspid valve surgery.
- STS (Society of Thoracic Surgeons) mortality risk score of ≥ 2 and < 6 for mitral valve repair or ≥ 2 and < 8 for mitral valve replacement at time of index procedure.
- Able to speak, read, and understand English
Who cannot join
- Pre-operative tricuspid regurgitation of 4+ (severe) at time of index procedure.
- Severe RV Dysfunction.
- Contraindication to exercise testing (i.e., Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, etc.).
- Unable to perform an exercise test due to clinical criteria such oxygen dependency, neuromuscular limitations, NYHA class 4, unstable angina, and postural hypotension.
- Surgical or interventional cardiac procedure or other intervention since the index procedure that in the opinion of the Investigator may confound data analysis.
- Left ventricular ejection fraction <30%.
- Subjects unwilling or unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Degenerative Mitral Regurgitation in Intermediate Risk Patients 65 or Older: Exercise Echocardiogram and HRQOL Post Surgery Preliminary Analysis
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
Read the detailed description
Severe mitral regurgitation is associated with significant morbidity and mortality. Mitral valve surgical repair has proven to be an effective and durable option in the treatment of symptomatic degenerative mitral regurgitation (MR).
Echocardiography remains a cornerstone in the evaluation of patients with degenerative (Type II) mitral regurgitation allowing for assessment of mitral anatomy, quantification of regurgitant severity, assessment of biventricular function, non-invasive measurement of pulmonary artery systolic pressures and identifying the presence of other valvular disease. The AHA/ACC Valvular Heart Disease Guidelines recommend the use of exercise echocardiography in the setting of mitral regurgitation to determine the degree of mitral regurgitation and pulmonary artery systolic pressures pre and post exercise in addition to an objective determination of the symptoms and exercise capacity.
Echocardiography (both resting and exercise modalities) is helpful in the post-mitral valve repair period in the assessment of the mitral valve gradient and recurrent mitral regurgitation. Symptomatic MR patients can have poor health-related quality of life (HRQOL) which improves and / or returns to comparable age-adjusted norms for reference populations after mitral valve repair or replacement.
To date, there is limited assessment of the degree of mitral regurgitation, mitral stenosis, and exercise capacity following both surgical and percutaneous mitral valve intervention as measured by exercise echocardiography. We propose that this modality with the addition of novel imaging technologies will provide a robust avenue for the assessment of these patients longitudinally. Additionally, assessment of HRQOL, including both the physical and mental health domains, will provide important information with which to guide patient care after mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Regurgitation
- Keywords
- degenerative mitral regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative Mitral Regurgitation | This cohort includes patients that have had mitral valve surgery for Degenerative Mitral Regurgitation (Type II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
To evaluate exercise duration and workload (METS) in patients who have undergone mitral valve surgery for degenerative mitral regurgitation
Measured: 6 to 36 months Post Index Procedure
Secondary outcomes (2)
Change in HRQOL
To determine HRQOL changes from baseline to intermediate term (6 to 36 months) in intermediate risk patients undergoing surgery for Degenerative Mitral Regurgitation
Measured: Baseline (Index procedure) up to 36 months after surgery
Change in mitral regurgitation
To determine change in the degree of mitral regurgitation
Measured: Pre-procedure up to 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Patrick McCarthy, MD, Northwestern University
- Investigators
- Patrick M McCarthy, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604745
- Sponsor's protocol ID
- STU00201771
- Acronym
- DMR
- Status last verified
- Mar 2021
- First submitted
- 10 Nov 2015
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degenerative Mitral Regurgitation in Intermediate Risk Patients 65 or Older: Exercise Echocardiogram and HRQOL Post Surgery Preliminary Analysis
- ClinicalTrials.gov ID
- NCT02604745
- Acronym / sponsor ID
- DMR / STU00201771
- Conditions
- Mitral Valve Insufficiency, Mitral Regurgitation
- Keywords
- degenerative mitral regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 13 Nov 2015 (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.
The main objective of this project is to determine intermediate-term echocardiographic outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
Detailed description
Severe mitral regurgitation is associated with significant morbidity and mortality. Mitral valve surgical repair has proven to be an effective and durable option in the treatment of symptomatic degenerative mitral regurgitation (MR).
Echocardiography remains a cornerstone in the evaluation of patients with degenerative (Type II) mitral regurgitation allowing for assessment of mitral anatomy, quantification of regurgitant severity, assessment of biventricular function, non-invasive measurement of pulmonary artery systolic pressures and identifying the presence of other valvular disease. The AHA/ACC Valvular Heart Disease Guidelines recommend the use of exercise echocardiography in the setting of mitral regurgitation to determine the degree of mitral regurgitation and pulmonary artery systolic pressures pre and post exercise in addition to an objective determination of the symptoms and exercise capacity.
Echocardiography (both resting and exercise modalities) is helpful in the post-mitral valve repair period in the assessment of the mitral valve gradient and recurrent mitral regurgitation. Symptomatic MR patients can have poor health-related quality of life (HRQOL) which improves and / or returns to comparable age-adjusted norms for reference populations after mitral valve repair or replacement.
To date, there is limited assessment of the degree of mitral regurgitation, mitral stenosis, and exercise capacity following both surgical and percutaneous mitral valve intervention as measured by exercise echocardiography. We propose that this modality with the addition of novel imaging technologies will provide a robust avenue for the assessment of these patients longitudinally. Additionally, assessment of HRQOL, including both the physical and mental health domains, will provide important information with which to guide patient care after mitral valve surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerative Mitral Regurgitation | – | –This cohort includes patients that have had mitral valve surgery for Degenerative Mitral Regurgitation (Type II) |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with a history of mitral valve surgery for Degenerative Mitral Regurgitation (Type II).
Key inclusion criteria (5 listed)
- Prior surgery for degenerative mitral regurgitation (DMR) at Northwestern Memorial Hospital performed by a single surgeon.
- Male and female ≥ 65 years of age at time of index procedure.
- Mitral Valve surgery performed > 6 months and <36 months at the time of consent. Concomitant procedures at time of index procedure may include incidental CAB, MAZE and tricuspid valve surgery.
- STS (Society of Thoracic Surgeons) mortality risk score of ≥ 2 and < 6 for mitral valve repair or ≥ 2 and < 8 for mitral valve replacement at time of index procedure.
- Able to speak, read, and understand English
Key exclusion criteria (7 listed)
- Pre-operative tricuspid regurgitation of 4+ (severe) at time of index procedure.
- Severe RV Dysfunction.
- Contraindication to exercise testing (i.e., Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, etc.).
- Unable to perform an exercise test due to clinical criteria such oxygen dependency, neuromuscular limitations, NYHA class 4, unstable angina, and postural hypotension.
- Surgical or interventional cardiac procedure or other intervention since the index procedure that in the opinion of the Investigator may confound data analysis.
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
Exercise Capacity
Time frame: 6 to 36 months Post Index Procedure
To evaluate exercise duration and workload (METS) in patients who have undergone mitral valve surgery for degenerative mitral regurgitation
2 secondary outcomes
Change in HRQOL
Time frame: Baseline (Index procedure) up to 36 months after surgery
Change in mitral regurgitation
Time frame: Pre-procedure up to 36 months after surgery
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 Apr 2021.
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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.
Patrick M McCarthy, MD principal investigator
Northwestern 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 Mitral Valve Insufficiency and Mitral Regurgitation, run by Northwestern University at 1 site in United States.
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 7 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 Apr 2021. 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 United States. 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?
Exercise Capacity (time frame: 6 to 36 months Post Index Procedure). 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 1 Apr 2021.