Clinical trial NCT02728739: Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
Official title: Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Mitral Regurgitation
Lead sponsor: Metanoic Health Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
First posted: 2016-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Grade 3 and above mitral regurgitation in acute heart failure.
timeFrame: 12 months
Secondary outcomes:
measure: Establish correlation between BNP level and severity of MR in acute HF
timeFrame: 12 months
measure: The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.
timeFrame: 12 month
Other outcomes:
Locations:
city: Chertsey
country: United Kingdom
facility: St Peter's Hospital, Guildford Road
state: Surrey
Study officials:
affiliation: Ashford & St Peter's Hospitals NHS Foundation Trust
name: Aigul Baltabaeva, MBBS MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.