Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients (MRAHF)

Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation; Acute Heart Failure
• Intervention / Treatment: Procedure: Transthoracic Echocardiogram (TTE) Assesment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • St Peter's Hospital, Guildford Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with BNP level (< 30pg/ml)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish correlation between BNP level and severity of MR in acute HF	Standard statistical analysis of BNP level and grade of MR severity	12 months
The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.	Standard statistical analysis of 2 sets of data	12 month

Collaborators and Investigators

• Sponsor: Metanoic Health Ltd.
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Aigul Baltabaeva, MBBS MD PhD, Ashford & St Peter's Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency
• Other Study ID Numbers: MHL-2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No