CompletedNot Applicable

The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery

Finland31 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * scheduled mitral valve prolapse repair surgery * able to give informed consent Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tricuspid annular plane systolic excursion (TAPSE)

Timeframe: Change from baseline TAPSE at hypercarbia (in approximately 30 min)

Mean pulmonary artery pressure (MPAP)

Timeframe: Change from baseline MPAP at hypercarbia (in approximately 30 min)

Trial details

NCT IDNCT02757573

SponsorTampere University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Heart; Decompensation, Right Ventricle trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.