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NCT02728739 Clinical Trial

Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

Mitral Regurgitation Clinical Trial

— MRAHF  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02728739
Other study ID # MHL-2016-001
Secondary ID
Status Completed
Phase N/A
First received March 24, 2016
Last updated February 2, 2018
Start date June 6, 2016
Est. completion date February 2018

Study information
Verified date February 2018
Source Metanoic Health Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date February 2018
Est. primary completion date December 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Acute Heart Failure patients admitted to the Hospital

- Elevated BNP level (>30pg/ml)

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United Kingdom St Peter's Hospital, Guildford Road Chertsey Surrey

Sponsors (2)
Lead Sponsor Collaborator
Metanoic Health Ltd. Abbott Vascular

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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