Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

NCT ID: NCT02728739

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-06

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this study is to determine the prevalence of moderate-to-severe Mitral Regurgitation (MR) in acute Heart Failure (HF) patients requiring hospital admission.

Detailed Description

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All patients admitted with symptoms of HF- (shortness of breath (SOB), peripheral oedema, palpitations and irregular heart beats) will be assessed by the Research Team. The level of BNP will be checked using a small device (i-STAT BNP) at the bedside. If results of the test suggest HF they will undergo special procedure called transthoracic echocardiography (TTE). TTE is an ultrasound scan of the heart which will enable the investigators' to grade severity of Mitral Regurgitation (MR) as well as strength of the heart muscle. The investigators will use bi-plane Simpton's method to calculate left ventricular (LV) ejection fraction (EF). Colour Doppler and PISA method will be used to quantify severity of MR or valve leak. Simultaneously there will be recording of heart sounds to find out if auscultation is reliable in identifying leaky valves.

Conditions

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Acute Heart Failure Mitral Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acute Heart Failure Patients

Acute Heart Failure patients with elevated levels of BNP ( \>30pg/ml) will undergo Transthoracic Echocardiogram (TTE) for grading of MR severity within 7 days.

Group Type EXPERIMENTAL

Transthoracic Echocardiogram (TTE) Assesment

Intervention Type PROCEDURE

Transthoracic Echocardiogram (TTE) will be carried out on all heart failure patients with elevated BNP level (\>30 pg/ ml) for grading of MR severity within 7 days.

Interventions

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Transthoracic Echocardiogram (TTE) Assesment

Transthoracic Echocardiogram (TTE) will be carried out on all heart failure patients with elevated BNP level (\>30 pg/ ml) for grading of MR severity within 7 days.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute Heart Failure patients admitted to the Hospital
* Elevated BNP level (\>30pg/ml)

Exclusion Criteria

* Patients with BNP level (\< 30pg/ml)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Metanoic Health Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aigul Baltabaeva, MBBS MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ashford & St Peter's Hospitals NHS Foundation Trust

Locations

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St Peter's Hospital, Guildford Road

Chertsey, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

References

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De Bonis M, Maisano F, La Canna G, Alfieri O. Treatment and management of mitral regurgitation. Nat Rev Cardiol. 2011 Nov 22;9(3):133-46. doi: 10.1038/nrcardio.2011.169.

Reference Type BACKGROUND
PMID: 22105677 (View on PubMed)

Enriquez-Sarano M, Sundt TM 3rd. Early surgery is recommended for mitral regurgitation. Circulation. 2010 Feb 16;121(6):804-11; discussion 812. doi: 10.1161/CIRCULATIONAHA.109.868083. No abstract available.

Reference Type BACKGROUND
PMID: 20159841 (View on PubMed)

Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.

Reference Type BACKGROUND
PMID: 15745978 (View on PubMed)

Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

Reference Type BACKGROUND
PMID: 16980116 (View on PubMed)

Berrill M, Beeton I, Fluck D, John I, Lazariashvili O, Stewart J, Ashcroft E, Belsey J, Sharma P, Baltabaeva A. Disproportionate Mitral Regurgitation Determines Survival in Acute Heart Failure. Front Cardiovasc Med. 2021 Dec 2;8:742224. doi: 10.3389/fcvm.2021.742224. eCollection 2021.

Reference Type DERIVED
PMID: 34926604 (View on PubMed)

Other Identifiers

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MHL-2016-001

Identifier Type: -

Identifier Source: org_study_id

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