NCT02728739

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

March 24, 2016

Last Update Submit

February 2, 2018

Conditions

Acute Heart FailureMitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Grade 3 and above mitral regurgitation in acute heart failure.

    TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.

    12 months

Secondary Outcomes (2)

  • Establish correlation between BNP level and severity of MR in acute HF

    12 months

  • The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.

    12 month

Study Arms (1)

Acute Heart Failure Patients

EXPERIMENTAL

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

Procedure: Transthoracic Echocardiogram (TTE) Assesment

Interventions

Transthoracic Echocardiogram (TTE) AssesmentPROCEDURE

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.

Acute Heart Failure Patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with BNP level (\< 30pg/ml)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Peter's Hospital, Guildford Road

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 22105677BACKGROUND

  • 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.

    PMID: 20159841BACKGROUND

  • 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.

    PMID: 15745978BACKGROUND

  • 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.

    PMID: 16980116BACKGROUND

  • 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.

    PMID: 34926604DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Aigul Baltabaeva, MBBS MD PhD

    Ashford & St Peter's Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 5, 2016

Study Start

June 6, 2016

Primary Completion

December 29, 2017

Study Completion

February 1, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

GB(1)