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Trial record 18 of 41 for:    FROVATRIPTAN

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
Sponsor:
Information provided by (Responsible Party):
Georg Goliasch, Medical University of Vienna

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).


Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: stress echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Stress testing arm
Stress testing of patients with functional mitral regurgitation.
Diagnostic Test: stress echocardiography
stress testing of patients with functional mitral regurgitation




Primary Outcome Measures :
  1. prevalence of severe dynamic FMR under stressed conditions [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


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

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Georg Goliasch, MD, PhD    +434040046140    georg.goliasch@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Georg Goliasch, Asc.Prof. Priv.Doz. Dr., PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03315429     History of Changes
Other Study ID Numbers: 1590/2017
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases