Acute Heart FailureMRAHFNCT02728739
Incidence of Significant Mitral Regurgitation in Acute Heart Failure Patients
A study testing Transthoracic Echocardiogram (TTE) Assesment in people with Acute Heart Failure and Mitral Regurgitation, run by Metanoic Health Ltd. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Heart Failure, Mitral Regurgitation
- What is being tested?
- Transthoracic Echocardiogram (TTE) Assesment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Heart Failure patients admitted to the Hospital
- Elevated BNP level (>30pg/ml)
Who cannot join
- Patients with BNP level (< 30pg/ml)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Peter's Hospital, Guildford Road
Chertsey, Surrey, KT16 0PZ
About this study
Official title: Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre
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.
Read the 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.
- Conditions
- Acute Heart Failure, Mitral Regurgitation
- Being tested
- Transthoracic Echocardiogram (TTE) Assesment
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiogram (TTE) AssesmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Heart Failure Patients | Experimental | Acute Heart Failure patients with elevated levels of BNP ( >30pg/ml) will undergo Transthoracic Echocardiogram (TTE) for grading of MR severity within 7 days. Receives: Procedure: Transthoracic Echocardiogram (TTE) Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 and above mitral regurgitation in acute heart failure.
TTE Grading is done on colour Doppler and proximal isovelocity surface area (PISA) method.
Measured: 12 months
Secondary outcomes (2)
Establish correlation between BNP level and severity of MR in acute HF
Standard statistical analysis of BNP level and grade of MR severity
Measured: 12 months
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start6 Jun 2016
- Primary completion29 Dec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metanoic Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Aigul Baltabaeva, MBBS MD PhD, Principal investigator, Ashford & St Peter's Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728739
- Sponsor's protocol ID
- MHL-2016-001
- Acronym
- MRAHF
- Status last verified
- Feb 2018
- First submitted
- 24 Mar 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22105677Enriquez-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.
PubMed 20159841Enriquez-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.
PubMed 15745978Nkomo 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.
PubMed 16980116Berrill 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.
PubMed 34926604
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Significant Mitral Regurgitation in Patients Presenting With Acute Heart Failure: Journey to Tertiary Centre
- ClinicalTrials.gov ID
- NCT02728739
- Acronym / sponsor ID
- MRAHF / MHL-2016-001
- Conditions
- Acute Heart Failure, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Metanoic Health Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Abbott Medical Devices
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Heart Failure Patients | Experimental | Procedure: Transthoracic Echocardiogram (TTE) AssesmentAcute Heart Failure patients with elevated levels of BNP ( >30pg/ml) will undergo Transthoracic Echocardiogram (TTE) for grading of MR severity within 7 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute Heart Failure patients admitted to the Hospital
- Elevated BNP level (>30pg/ml)
Key exclusion criteria (1 listed)
- Patients with BNP level (< 30pg/ml)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic Echocardiogram (TTE) AssesmentTransthoracic 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. | Procedure or surgery | Acute Heart Failure Patients |
Primary outcome
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.
2 secondary outcomes
Establish correlation between BNP level and severity of MR in acute HF
Time frame: 12 months
The validity of Hospital Episode Statistics (HES) data against prevalence of grade 3-4 MR in the study.
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Background: PubMed 22105677De 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.
- Background: PubMed 20159841Enriquez-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.
- Background: PubMed 15745978Enriquez-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.
- Background: PubMed 16980116Nkomo 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.
- Derived from this study: PubMed 34926604Berrill 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aigul Baltabaeva, MBBS MD PhD principal investigator
Ashford & St Peter's Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Echocardiogram (TTE) Assesment in people with Acute Heart Failure and Mitral Regurgitation, run by Metanoic Health Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 and above mitral regurgitation in acute heart failure. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728739, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.