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Clinical Trials/NCT02728739
NCT02728739
Completed
Not Applicable

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

Metanoic Health Ltd.1 site in 1 country500 target enrollmentJune 6, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Heart Failure
Sponsor
Metanoic Health Ltd.
Enrollment
500
Locations
1
Primary Endpoint
Grade 3 and above mitral regurgitation in acute heart failure.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2016
End Date
February 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Metanoic Health Ltd.
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Grade 3 and above mitral regurgitation in acute heart failure.

Time Frame: 12 months

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

Secondary Outcomes

  • 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 Sites (1)

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