Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure (ALLEGRO)
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|ClinicalTrials.gov Identifier: NCT03315429|
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : November 6, 2017
Chronic heart failure (HF) is frequently accompanied by functional mitral regurgitation (FMR) caused by left ventricular (LV) remodeling and subsequent papillary muscle displacement resulting in mitral valve (MV) leaflet tethering, dilatation and flattening of the mitral annulus and reduced closing forces. Up to moderate FMR affects the majority of patients with systolic heart failure - roughly 80% - still independently increasing mortality. Every fifth patient with chronic heart failure experiences a progression of FMR during the first three years of follow up despite guideline directed heart failure therapy, which is independently associated with a poor prognosis. Furthermore, MR is well known to have a strong dynamic component not only during the cardiac cycle at rest and with exercise.
Aims of the study:
The investigators therefore aim to assess whether stress tests in patients with functional mitral regurgitation unmasks significant dynamic mitral regurgitation or might aid to identify patients at risk of FMR progression in patients with functional mitral regurgitation in heart failure with reduced ejection fraction (HFrEF) under guideline directed medical therapy.
The investigators will prospectively perform stress tests in all patients with non-severe FMR that are routinely seen in the heart failure outpatient clinic.
Patients with stable chronic heart failure on optimal medical therapy, who undergo routine ambulatory clinical control visits in the heart failure outpatient ward of the Medical University of Vienna, will be included in the present study. A written informed consent will be obtained before inclusion. Inclusion criteria will be a non-severe FMR, an age of at least 18 years and stable heart failure related medical therapy in the last 3 months.
All patients that are willing to participate will undergo stress testing (i.e. volume challenge and low dose dobutamine stress) to determine whether patients display severe dynamic FMR under stress conditions. Within the registry patients will be followed-up during routine ambulatory visits for three years. Patients with severe dynamic functional mitral regurgitation will be compared to patients without severe dynamic FMR. Record of clinical events during the FUP will be performed. Routine laboratory parameters, have been measured at inclusion. Additionally, neurohormone patterns will be measured at baseline and at peak stress.
Expecting a prevalence of severe dynamic FMR of 20%, the investigators would include a total of 150 chronic heart failure patients taking also into account a study-dropouts of 20% ( loss of follow-up and mortality).
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Diagnostic Test: stress echocardiography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unmasking the Dynamic Component in Functional Mitral Regurgitation in Chronic Heart Failure|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||October 31, 2021|
Stress testing arm
Stress testing of patients with functional mitral regurgitation.
Diagnostic Test: stress echocardiography
stress testing of patients with functional mitral regurgitation
- prevalence of severe dynamic FMR under stressed conditions [ Time Frame: 3 years ]
- Identification of a relationship between dynamic FMR (defined as advance of at least one grade in severity with transition to at least moderate during stress) and FMR progression during rest within the 3 year follow-up period. [ Time Frame: 3 years ]
- correlation of the prevalence of dynamic FMR with the dynamic levels of neurohormones [ Time Frame: 3 years ]
- Establishment of an association between dynamic FMR and outcome (combined measure consisting of hospitalization for heart failure and/or death) during the follow-up period [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315429
|Contact: Georg Goliasch, MD, PhDfirstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Georg Goliasch, MD, PhD +434040046140 email@example.com|