Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure (ALLEGRO)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
stress echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- non-severe FMR,
- age of at least 18 years,
- stable heart failure related medical therapy in the last 3 months.
Exclusion criteria
- non-willing to participate
- myocardial infarction,
- cardiac decompensation within the last 3 months,
- pregnancy,
- life expectancy of less than 1 year for non cardiac reasons.
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stress testing arm
Arm Description
Stress testing of patients with functional mitral regurgitation.
Outcomes
Primary Outcome Measures
prevalence of severe dynamic FMR under stressed conditions
Secondary Outcome Measures
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.
correlation of the prevalence of dynamic FMR with the dynamic levels of neurohormones
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
Full Information
NCT ID
NCT03315429
First Posted
October 10, 2017
Last Updated
November 3, 2017
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03315429
Brief Title
Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure
Acronym
ALLEGRO
Official Title
Unmasking the Dynamic Component in Functional Mitral Regurgitation in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background:
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.
Study design:
The investigators will prospectively perform stress tests in all patients with non-severe FMR that are routinely seen in the heart failure outpatient clinic.
Study patients:
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.
Methods:
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.
Sample size:
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress testing arm
Arm Type
Other
Arm Description
Stress testing of patients with functional mitral regurgitation.
Intervention Type
Diagnostic Test
Intervention Name(s)
stress echocardiography
Intervention Description
stress testing of patients with functional mitral regurgitation
Primary Outcome Measure Information:
Title
prevalence of severe dynamic FMR under stressed conditions
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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
Title
correlation of the prevalence of dynamic FMR with the dynamic levels of neurohormones
Time Frame
3 years
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-severe FMR,
age of at least 18 years,
stable heart failure related medical therapy in the last 3 months.
Exclusion criteria
non-willing to participate
myocardial infarction,
cardiac decompensation within the last 3 months,
pregnancy,
life expectancy of less than 1 year for non cardiac reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Goliasch, MD, PhD
Phone
+434040046140
Email
georg.goliasch@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Goliasch, MD, PhD
Phone
+434040046140
Email
georg.goliasch@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure
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