Heart; Decompensation, Right VentricleNCT02757573
The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
A study testing Hypercarbia in people with Heart; Decompensation, Right Ventricle and Echocardiography, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart; Decompensation, Right Ventricle, Echocardiography, Hypercapnia
- What is being tested?
- Hypercarbia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- scheduled mitral valve prolapse repair surgery
- able to give informed consent
Who cannot join
- preoperative right ventricular dysfunction or pulmonary hypertension
- significant tricuspid regurgitation
- congenital heart defect
- ventricular dyssynchrony or wide QRS-complex on ECG (> 130 ms)
- prior myocardial infarction (within tree months) or pericardial constriction
- preoperative left ventricular (LV) dysfunction, i.e. LV ejection fraction under 40 %
- if the scheduled repair by plastic procedure has been converted to mitral valve replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.
Read the detailed description
The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Investigators hypothesize that induced mild hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. And this right ventricle effect could be noticed by echocardiography.
- Being tested
- Hypercarbia
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypercarbiaProcedure or surgery
PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Hypercarbia | Experimental | Hypercarbia: PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation. Receives: Procedure: Hypercarbia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid annular plane systolic excursion (TAPSE)
TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Measured: Change from baseline TAPSE at hypercarbia (in approximately 30 min)
Mean pulmonary artery pressure (MPAP)
MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Measured: Change from baseline MPAP at hypercarbia (in approximately 30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Decompensation, Right VentricleStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kati Järvelä, Tampere University Hospital
- Investigators
- Kati Järvelä, MD, Principal investigator, Tampere University HospitalKati Rautaneva, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757573
- Sponsor's protocol ID
- R16005
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2016
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tujunen MLJ, Lahti J, Kiiski H, Kuitunen AH, Tuohinen SS, Rautaneva K, Jalkanen VL, Huhtala H, Jarvela KM. Right Ventricular Response to Hypercapnia After Mitral Valve Repair: A Hemodynamic Assessment. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70064. doi: 10.1111/aas.70064.
PubMed 40490845
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
- ClinicalTrials.gov ID
- NCT02757573
- Acronym / sponsor ID
- R16005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 May 2016 (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 aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.
Detailed description
The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Investigators hypothesize that induced mild hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. And this right ventricle effect could be noticed by echocardiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypercarbia | Experimental | Procedure: HypercarbiaHypercarbia: PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled mitral valve prolapse repair surgery
- able to give informed consent
Key exclusion criteria (7 listed)
- preoperative right ventricular dysfunction or pulmonary hypertension
- significant tricuspid regurgitation
- congenital heart defect
- ventricular dyssynchrony or wide QRS-complex on ECG (> 130 ms)
- prior myocardial infarction (within tree months) or pericardial constriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypercarbiaPaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation. | Procedure or surgery | Hypercarbia |
Primary outcome
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: Change from baseline TAPSE at hypercarbia (in approximately 30 min)
TAPSE will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
Mean pulmonary artery pressure (MPAP)
Time frame: Change from baseline MPAP at hypercarbia (in approximately 30 min)
MPAP will be measured at baseline (PaCO2 5 kPa) and at hypercarbia (PaCO2 7.5 kPa)
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 25 Apr 2023.
- Derived from this study: PubMed 40490845Tujunen MLJ, Lahti J, Kiiski H, Kuitunen AH, Tuohinen SS, Rautaneva K, Jalkanen VL, Huhtala H, Jarvela KM. Right Ventricular Response to Hypercapnia After Mitral Valve Repair: A Hemodynamic Assessment. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70064. doi: 10.1111/aas.70064.
- Individual participant dataSharing planned: Undecided
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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.
Kati Järvelä, MD principal investigator
Tampere University Hospital
Kati Rautaneva, MD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypercarbia in people with Heart; Decompensation, Right Ventricle and Echocardiography, run by Tampere University Hospital at 1 site in Finland.
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 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 25 Apr 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 Finland. 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?
Tricuspid annular plane systolic excursion (TAPSE) (time frame: Change from baseline TAPSE at hypercarbia (in approximately 30 min)). The study lists 2 primary outcomes in all. 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 NCT02757573, which also lists 1 linked publication.
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 25 Apr 2023.