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

Primary Purpose

Acute Heart Failure, Mitral Regurgitation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transthoracic Echocardiogram (TTE) Assesment
Sponsored by
Metanoic Health Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • St Peter's Hospital, Guildford Road

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Heart Failure Patients

Arm Description

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

Outcomes

Primary Outcome Measures

Grade 3 and above mitral regurgitation in acute heart failure.
TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.

Secondary Outcome Measures

Establish correlation between BNP level and severity of MR in acute HF
Standard statistical analysis of BNP level and grade of MR severity
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

Full Information

First Posted
March 24, 2016
Last Updated
February 2, 2018
Sponsor
Metanoic Health Ltd.
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02728739
Brief Title
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
Acronym
MRAHF
Official Title
Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 6, 2016 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metanoic Health Ltd.
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute Heart Failure Patients
Arm Type
Experimental
Arm Description
Acute Heart Failure patients with elevated levels of BNP ( >30pg/ml) will undergo Transthoracic Echocardiogram (TTE) for grading of MR severity within 7 days.
Intervention Type
Procedure
Intervention Name(s)
Transthoracic Echocardiogram (TTE) Assesment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grade 3 and above mitral regurgitation in acute heart failure.
Description
TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Establish correlation between BNP level and severity of MR in acute HF
Description
Standard statistical analysis of BNP level and grade of MR severity
Time Frame
12 months
Title
The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.
Description
Standard statistical analysis of 2 sets of data
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute Heart Failure patients admitted to the Hospital Elevated BNP level (>30pg/ml) Exclusion Criteria: Patients with BNP level (< 30pg/ml)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aigul Baltabaeva, MBBS MD PhD
Organizational Affiliation
Ashford & St Peter's Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Peter's Hospital, Guildford Road
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22105677
Citation
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.
Results Reference
background
PubMed Identifier
20159841
Citation
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.
Results Reference
background
PubMed Identifier
15745978
Citation
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.
Results Reference
background
PubMed Identifier
16980116
Citation
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.
Results Reference
background
PubMed Identifier
34926604
Citation
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.
Results Reference
derived

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Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

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