Heart Failure With Preserved Ejection FractionOPTMISE-HFpEFNCT06311552
Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.
An observational study of Heart Failure With Preserved Ejection Fraction, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2022to 30 Nov 2023
- Phase
- Observational
- 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
Study population: Either a clinical diagnosis of HFpEF, be at risk of or pre-HFpEF
Who may be able to join
- Males or females aged >18 years
- Either a clinical diagnosis of HFpEF, be at risk of or pre- HFpEF
Who cannot join
- Absolute contraindication to MRI
- Unable to read/understand English sufficiently to provide informed consent
- Pregnancy
- Unable to consent due to lack of mental capacity
- Current cancer diagnosis and actively undergoing treatment
- Inability to exercise on the MRI ergometer
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.
- Being tested
- Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scannerOther
Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner
| Study group | Role | What they receive |
|---|---|---|
| CMR scan on either a 1.5- or 3-Tesla scanner | Not described Receives: Other: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper).
Measured: By end of study - 30/04/2023
Secondary outcomes (3)
To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study
Measured: By end of study - 30/04/2023
To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group.
Measured: By end of study - 30/04/2023
To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study
Measured: By end of study - 30/04/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start31 Jan 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311552
- Sponsor's protocol ID
- 0856
- Acronym
- OPTMISE-HFpEF
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising CMR Scan Acquisitions for Novel Equipment/Sequences in Clinical Cardiovascular Populations.
- ClinicalTrials.gov ID
- NCT06311552
- Acronym / sponsor ID
- OPTMISE-HFpEF / 0856
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- 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 develop robust protocols for the optimisation of novel hardware, software and exercise equipment in the magnetic resonance imaging (MRI) environment in various cohorts with cardiovascular disease (CVD) with the first study focusing on those with established heart failure with preserved ejection fraction (HFpEF) or those at risk of or with pre-HFpEF.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR scan on either a 1.5- or 3-Tesla scanner | – | Other: Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Either a clinical diagnosis of HFpEF, be at risk of or pre-HFpEF
Key inclusion criteria (2 listed)
- Males or females aged >18 years
- Either a clinical diagnosis of HFpEF, be at risk of or pre- HFpEF
Key exclusion criteria (7 listed)
- Absolute contraindication to MRI
- Unable to read/understand English sufficiently to provide informed consent
- Pregnancy
- Unable to consent due to lack of mental capacity
- Current cancer diagnosis and actively undergoing treatment
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 |
|---|---|---|
| Participants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scannerParticipants will undergo a comprehensive CMR scan on either a 1.5- or 3-Tesla scanner | Other | CMR scan on either a 1.5- or 3-Tesla scanner |
Primary outcome
To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper).
Time frame: By end of study - 30/04/2023
3 secondary outcomes
To determine the reproducibility of the exercise CMR protocols in a test-retest reproducibility sub-study
Time frame: By end of study - 30/04/2023
To determine the optimal scan acquisition protocol for Magnetic Resonance Spectroscopy (MRS) both H+ and 31P using the phosphorous coil in each patient group.
Time frame: By end of study - 30/04/2023
To determine the reproducibility of the MRS protocols in a test-retest reproducibility sub-study
Time frame: By end of study - 30/04/2023
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 15 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University of Leicester 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 7 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 15 Mar 2024. 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?
To develop CMR scanning protocols which acquire the highest quality images during incremental exercise using a stepper ergometer (Ergospect Cardio-stepper). (time frame: By end of study - 30/04/2023). 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 15 Mar 2024.