Heart Failure With Preserved Ejection FractionNCT03226652
Heart Function in Patients Assessed for Sleep Apnoea
An observational study of Heart Failure With Preserved Ejection Fraction and Sleep Disordered Breathing, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Sleep Disordered Breathing, Heart Failure With Normal Ejection Fraction
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred from primary and secondary care for SDB assessment.
Who may be able to join
- Aged ≥40 years and referred for respiratory polygraphy
Who cannot join
- Previous diagnosis of Heart Failure
- Treated sleep disordered breathing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Function in Patients Assessed for Sleep Disordered Breathing (SDB)
This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).
Read the detailed description
Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Sleep Disordered Breathing, Heart Failure With Normal Ejection Fraction, Obstructive Sleep Apnea, Central Sleep Apnea, Heart Failure
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Apnea, Central, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinically suspected sleep disordered breathing (SDB) | Patients referred for Sleep disordered breathing assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB)
The diagnosis of HFpEF was established using criteria set out in the European Society for Cardiology (ESC) guidelines based on clinical symptoms and/or signs, biomarker analysis (NT-proBNP) and evidence of structural cardiac remodeling or diastolic dysfunction on transthoracic echocardiography.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start24 Jul 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Martin R Cowie, MD MSc, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226652
- Sponsor's protocol ID
- 17IC3980
- Status last verified
- Feb 2021
- First submitted
- 20 Jul 2017
- Last updated
- 17 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Function in Patients Assessed for Sleep Disordered Breathing (SDB)
- ClinicalTrials.gov ID
- NCT03226652
- Acronym / sponsor ID
- 17IC3980
- Conditions
- Heart Failure With Preserved Ejection Fraction, Sleep Disordered Breathing, Heart Failure With Normal Ejection Fraction, Obstructive Sleep Apnea, Central Sleep Apnea, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 17 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).
Detailed description
Patients with sleep disordered breathing (SDB) and those with heart failure with preserved ejection fraction (HFpEF) share similar characteristics. Increasing age, hypertension, obesity, diabetes mellitus and atrial fibrillation are well recognised links in both groups. It also known that SDB is common in patients with heart failure, both with reduced and preserved ejection fraction. It is therefore hypothesised that among patients being referred for SDB assessment, we can identify a group with unrecognised HFpEF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinically suspected sleep disordered breathing (SDB) | – | –Patients referred for Sleep disordered breathing assessment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred from primary and secondary care for SDB assessment.
Key inclusion criteria (1 listed)
- Aged ≥40 years and referred for respiratory polygraphy
Key exclusion criteria (2 listed)
- Previous diagnosis of Heart Failure
- Treated sleep disordered breathing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB)
Time frame: Baseline
The diagnosis of HFpEF was established using criteria set out in the European Society for Cardiology (ESC) guidelines based on clinical symptoms and/or signs, biomarker analysis (NT-proBNP) and evidence of structural cardiac remodeling or diastolic dysfunction on transthoracic echocardiography.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Martin R Cowie, MD MSc principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Sleep Disordered Breathing, run by Imperial College London 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 1 inclusion and 2 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 17 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Unrecognised Heart Failure With Preserved Ejection Fraction (HFpEF) in Cohort With Clinically Suspected Sleep Disordered Breathing (SDB) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2021.