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Completed

NCT Number: NCT02728739

Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients

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.

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Key information

Conditions

Acute Heart Failure Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Peter's Hospital, Guildford Road

Chertsey, Surrey, KT16 0PZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Transthoracic Echocardiogram (TTE) Assesment

Procedure

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 outcomes

  1. 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

  1. Establish correlation between BNP level and severity of MR in acute HF

    Time frame: 12 months

    Standard statistical analysis of BNP level and grade of MR severity

  2. The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.

    Time frame: 12 month

    Standard statistical analysis of 2 sets of data

Sponsors and collaborators

Lead sponsor

Metanoic Health Ltd.

Industry

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Acronym: MRAHF

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 5, 2016
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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