18 and older, any sex, with Cardiomyopathy or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in FMR SeverityPrimary· Pre-Intervention and Post-Intervention (12 Months)
The Severity (grade 0 to 4+) of mitral regurgitation of mitral regurgitation is measured using cardiac echocardiography and/or MRI (per physician's discretion).
Grade 0: None Grade 1 (Mild): Small, restricted jet of regurgitation with minimal impact on the heart's function. Typically, no symptoms and normal or near-normal left ventricular function.
Grade 2 (Moderate): Moderate jet size with some effect on the heart, but symptoms may still be absent or minimal. Mild to moderate left ventricular dilation may be present.
Grade 3 (Moderately Severe): Larger jet, more significant regurgitation,
The number of participants who are deceased will be collected throughout the study at discharge and planned follow up visits.
up to 20 days post-Intervention
Group
Value
95% CI
UMA (Group 1)
0
12 months post-intervention
Group
Value
95% CI
UMA (Group 1)
0
Number of Major Adverse Cardiac Events (MACE)Secondary· Up to 12 months post -intervention
MACE is defined as a composite of clinical events comprised of the following:
* Death
* Stroke
* Worsening heart failure (+1 New York Heart Association (NYHA) class)
* Congestive heart failure (CHF) hospitalization
* Mitral valve re-intervention
Congestive heart failure (CHF) hospitalization
Group
Value
95% CI
UMA (Group 1)
1
Death
Group
Value
95% CI
UMA (Group 1)
0
Mitral valve re-intervention
Group
Value
95% CI
UMA (Group 1)
0
Stroke
Group
Value
95% CI
UMA (Group 1)
0
Worsening heart failure (+1 New York Heart Association (NYHA) class)
Participants will be asked to measure their perceived quality of life on a scale from 0 to 100 where 0 indicates "worst imaginable health state" and 100 indicates "best imaginable health state".
Baseline
Group
Value
95% CI
UMA (Group 1)
69.0
± 19.0
Post-Intervention (Month 12)
Group
Value
95% CI
UMA (Group 1)
76.9
± 16.9
Change in Minnesota Living With Heart Failure (MLHF) Questionnaire ScoreSecondary· Baseline, Post-Intervention (Month 12)
The Minnesota Living with Heart Failure Questionnaire is a 21-item questionnaire that asks participants to describe how much their heart failure has affected life during the past month (4 weeks). Participants are asked if their heart failure prevented them from living as they want when completing daily tasks. Responses are rated on a scale from 0 to 5; 0 represents "no", 1 represents "very little" and 5 represents "very much" on a continuum. The MLHF score is obtained by summing the subjects responses. A minimum score is 0 indicating no affect to life and a maximum score is 105 indicating the
Baseline
Group
Value
95% CI
UMA (Group 1)
44.2
± 31.3
12 months Post-Intervention
Group
Value
95% CI
UMA (Group 1)
30.9
± 28.0
Change in Functional Status Assessed by 6-Minute Walk Test (6MWT)Secondary· Baseline, Post-intervention (Month 6), Post-Intervention (Month 12)
Functional status will be measured by a 6-minute walk test, which assesses the distance walked (in feet) on a flat, hard surface in a period of 6 minutes (the 6MWD). The test is used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. Optimal reference equations from healthy population-based samples using standardized 6MWT methods are not yet available. A low 6MWD is nonspecific and nondiagnostic. When the 6MWD is reduced, a thorough search for the cause of the impairment is warranted.
Baseline
Group
Value
95% CI
UMA (Group 1)
1048.4
± 293.7
12 months Post-Intervention
Group
Value
95% CI
UMA (Group 1)
1210.6
± 203.6
All Cause Readmission RateSecondary· Post Surgery (Up to 30 Days)
Readmission rate will be calculated for any cause within the first 30 days following surgery throughout the duration of the study.
Post-Surgery (up to 30 days)
Group
Value
95% CI
UMA (Group 1)
2
Post-Surgery (30 days through 12 Months)
Group
Value
95% CI
UMA (Group 1)
4
Heart Failure Readmission RateSecondary· Post Surgery (Up to 30 Days)
Readmission rate will be calculated for heart failure after 30 days following surgery throughout the duration of the study. Classification of readmission as heart failure related requires at least 2 out of the following signs and symptoms of acute decompensated heart failure:
* Dyspnea felt related to HF
* Treatment with intravenous diuretic, vasodilator or inotropic therapy
* X ray evidence of pulmonary edema or pulmonary vascular congestion
* Rales on physical exam
* Pulmonary capillary wedge pressure (PCWP) or LVEDP \> 18mm Hg
Group
Value
95% CI
UMA (Group 1)
0
Change in Left Ventricular VolumeSecondary· Baseline, Post-Intervention (Month 6), Post-Intervention (Month 12)
Change in left ventricular volume at 6- and 12-month post-intervention compared to baseline as measured by as measured by the left ventricular end-diastolic diameter determined by echocardiogram.
Baseline
Group
Value
95% CI
UMA (Group 1)
5.4
± 0.8
12 months Post-Intervention
Group
Value
95% CI
UMA (Group 1)
4.8
± 0.8
Change in Ejection FractionSecondary· Baseline, Post-Intervention (Month 12)
Change in left ventricular ejection fraction at 12- months post-intervention compared to baseline as measured by echocardiogram.
Baseline
Group
Value
95% CI
UMA (Group 1)
45
± 14
12 months post-intervention
Group
Value
95% CI
UMA (Group 1)
46
± 14
Adverse events — posted to ClinicalTrials.gov
Time frame: Considering the observational nature of this study, and the absence of any experimental procedures, adverse event (AE) reporting was limited only to those events that occurred from the specific non-standard-of-care lab procedures that were performed at 6- and 12-month visits..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
The technique used in current clinical practice is undersizing mitral annuloplasty (UMA), in which a prosthetic ring is implanted onto the mitral valve to correct the leakage. Though widely adopted, durability of the repair is less, as 58% of the patients present with recurrent FMR within 2 years. There are no specific algorithms to predict who might have UMA failure, but research indicates that some geometric indices might be strong predictors. The investigators are interested in testing the hypothesis that, elevated lateral inter-papillary muscle separation (IPMS) is a predictor of post-UMA recurrence of FMR at 12 months. In the first part of this study, the study team will measure lateral IPMS before surgery and relate to post-surgery FMR severity at discharge/30 days, 6 months and 12 months.
A relatively newer technique is papillary muscle approximation (PMA), in which a suture draws together the two muscles that connect the mitral valve to the heart muscle prior to performing UMA. This reduces the lateral inter-papillary muscle separation (IPMS) and is expected to improve the durability of UMA. In the second part of this study, the investigators will perform PMA and UMA together and determine if FMR severity is reduced at discharge/30 days, 6 months and 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 16 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03366649.