CClinicalTrials.gg
Status unknownNCT03315429ALLEGROUpdated Nov 6, 2017

Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure

An interventional study of stress echocardiography in Heart Failure, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • non-severe FMR,
  • age of at least 18 years,
  • stable heart failure related medical therapy in the last 3 months.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Stress testing arm

    Stress testing of patients with functional mitral regurgitation.

    Diagnostic Test: stress echocardiography

Interventions

  • Diagnostic teststress echocardiography

    stress testing of patients with functional mitral regurgitation

05

What researchers measure

Primary outcomes

  1. prevalence of severe dynamic FMR under stressed conditions

    Time frame: 3 years

Secondary outcomes

  1. 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

  2. correlation of the prevalence of dynamic FMR with the dynamic levels of neurohormones

    Time frame: 3 years

  3. 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

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03315429
Lead sponsor
Medical University of Vienna
Responsible party
Georg Goliasch (Asc.Prof. Priv.Doz. Dr., PhD, Medical University of Vienna) — Principal investigator
First posted
Oct 20, 2017
Start date
Nov 1, 2017
Primary completion
Oct 31, 2018 (estimated)
Completion
Oct 31, 2021 (estimated)
Last update
Nov 6, 2017

Study contacts

Georg Goliasch, MD, PhD
Contact
georg.goliasch@meduniwien.ac.at
+434040046140

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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