Mitral Valve RegurgitationNCT03154034
Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation
An observational study of Mitral Valve Regurgitation and Pulmonary Hypertension, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation, Pulmonary Hypertension
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2014to 31 Aug 2018
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic, severe mitral regurgitation. Aetiology and treatment of mitral regurgitation do not affect enrollment.
Who may be able to join
- symptomatic, severe mitral regurgitation
- referral for diagnostic work-up and heart team discussion
- declaration of informed consent
Who cannot join
- contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
- pregnancy
- exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
- no acceptable acoustic window at rest
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Regensburg - Department of Internal Medicine II
Regensburg, 93053
About this study
Official title: Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study
The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.
- Conditions
- Mitral Valve Regurgitation, Pulmonary Hypertension
- Keywords
- Stress echocardiography, Cardiopulmonary exercise testing, ergospirometry
- Medical subject headings
- Mitral Valve Insufficiency, Hypertension, Pulmonary
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 |
|---|---|---|
| Severe mitral regurgitation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise-induced systolic pulmonary arterial pressure
exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography
Measured: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year
Secondary outcomes (1)
peak oxygen uptake (peakVO2)
peak oxygen uptake measured by ergospirometry
Measured: Change from Baseline peakVO2 at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start13 Aug 2014
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexander Dietl, University Hospital Regensburg
- Investigators
- Alexander Dietl, MD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154034
- Sponsor's protocol ID
- UHRegensburg1
- Status last verified
- Oct 2021
- First submitted
- 10 May 2017
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study
- ClinicalTrials.gov ID
- NCT03154034
- Acronym / sponsor ID
- UHRegensburg1
- Conditions
- Mitral Valve Regurgitation, Pulmonary Hypertension
- Keywords
- Stress echocardiography, Cardiopulmonary exercise testing, ergospirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- 13 Aug 2014 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 15 May 2017 (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 purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe mitral regurgitation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic, severe mitral regurgitation. Aetiology and treatment of mitral regurgitation do not affect enrollment.
Key inclusion criteria (3 listed)
- symptomatic, severe mitral regurgitation
- referral for diagnostic work-up and heart team discussion
- declaration of informed consent
Key exclusion criteria (4 listed)
- contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
- pregnancy
- exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
- no acceptable acoustic window at rest
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-induced systolic pulmonary arterial pressure
Time frame: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year
exercise-induced systolic pulmonary arterial pressure measured by stress- echocardiography
1 secondary outcome
peak oxygen uptake (peakVO2)
Time frame: Change from Baseline peakVO2 at 1 year
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 11 Oct 2021.
- 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.
Alexander Dietl, MD principal investigator
University Hospital Regensburg
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 Regurgitation and Pulmonary Hypertension, run by University Hospital Regensburg at 1 site in Germany.
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 3 inclusion and 4 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 11 Oct 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 Germany. 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-induced systolic pulmonary arterial pressure (time frame: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 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 11 Oct 2021.