Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

Not Applicable

Completed

• Conditions: Acute Heart Failure; Mitral Regurgitation
• Interventions: Procedure: Transthoracic Echocardiogram (TTE) Assesment

• Registration Number: NCT02728739
• Lead Sponsor: Metanoic Health Ltd.

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.

Study Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-05
• Study Start: 2016-06-06
• Primary Completion: 2017-12-29
• Status Verified: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Grade 3 and above mitral regurgitation in acute heart failure.	12 months	TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.

Secondary Outcome Measures

Name	Time	Method
Establish correlation between BNP level and severity of MR in acute HF	12 months	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.	12 month	Standard statistical analysis of 2 sets of data

Trial Locations

Locations (1)

St Peter's Hospital, Guildford Road; 🇬🇧 Chertsey, Surrey, United Kingdom