Trial Outcomes & Findings for Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation (NCT NCT01172184)
NCT ID: NCT01172184
Last Updated: 2011-06-07
Results Overview
Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.
COMPLETED
111 participants
1 year
2011-06-07
Participant Flow
The present study enrolled 111 patients with severe mitral regurgitation (MR) who had undergone cardiac catheterization in Kaohsiung veterans general hospital.
Participant milestones
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
Baseline characteristics by cohort
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
|
Age Continuous
|
68 years
STANDARD_DEVIATION 18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Severe mitral regurgitation affects the accuracy of left ventricular filling pressure estimated by tissue Doppler imaging. Therefore, we conducted this study using left atrial parameters to assess left ventricular filling pressure in patients with severe mitral regurgitation.
Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.
Outcome measures
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 Participants
|
|---|---|
|
Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization
|
25.5 mmHg
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: baseline and 1 yearAfter operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.
Outcome measures
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 Participants
|
|---|---|
|
Number of Participants With Post-operation Atrial Fibrillation
|
36 participants
|
SECONDARY outcome
Timeframe: 1-2 yearsAfter discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.
Outcome measures
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 Participants
|
|---|---|
|
Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period
|
9 participants
|
Adverse Events
Patients With Either Chronic or Acute Mitral Regurgitation
Serious adverse events
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 participants at risk
|
|---|---|
|
Cardiac disorders
Heart failure requiring rehospitalizaion
|
8.1%
9/111 • All patients with severe mitral regurgitation received mitral valve replacement during index hospitalization. In-hospital mortality, and post-operative atrial fibrillation were recorded. The mean hospital course was 13 days.
After discharge from index hospitalization, patients received regular follow-up for heart failure event requiring rehospitalization for 1 year.
|
Other adverse events
| Measure |
Patients With Either Chronic or Acute Mitral Regurgitation
n=111 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
minor bleeding event
|
1.8%
2/111 • Number of events 2 • All patients with severe mitral regurgitation received mitral valve replacement during index hospitalization. In-hospital mortality, and post-operative atrial fibrillation were recorded. The mean hospital course was 13 days.
After discharge from index hospitalization, patients received regular follow-up for heart failure event requiring rehospitalization for 1 year.
|
Additional Information
Dr. Shih-Hung Hsiao
Kaohsiung veterans general hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place