Heart FailureNCT02888561
Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction
An observational study of Heart Failure, run by King's College London at 1 site in United Kingdom.
Trial summary
Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Dobutamine and Nitrite
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Jun 2018
- 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: Patients referred for diagnostic coronary angiography following a diagnosis of heart failure, with a left ventricular ejection fraction of less than or equal to 40%.
Who may be able to join
- Left Ventricular Ejection Fraction <40%
- Patients aged >18 years
- Able to provide written consent
Who cannot join
- Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects
- Haemodynamic Instability
- Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust
London, SE17EH
Natalia Briceno, MBBS BSc, natalia.briceno@kcl.ac.uk
Divaka Perera, MD, divaka.perera@kcl.ac.uk
About this study
Official title: The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure
Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.
- Conditions
- Heart Failure
- Being tested
- Dobutamine, Nitrite
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Dobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.
NitriteDrug
Nitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow (average peak velocity)
Measured: During procedure.
left ventricular stroke work
Measured: during procedure
Secondary outcomes (7)
rate pressure product
Measured: during procedure
pressure volume area
Measured: during procedure
coronary microvascular resistance
Measured: during procedure
stroke volume
Measured: during procedure
Distal tissue perfusion
Measured: during procedure
Magnitude of forward compression wave
Measured: during procedure
magnitude of backward expansion wave
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by King's 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888561
- Sponsor's protocol ID
- 199826
- Status last verified
- May 2016
- First submitted
- 30 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dobutamine and Nitrite on Myocardial Supply and Demand in Heart Failure
- ClinicalTrials.gov ID
- NCT02888561
- Acronym / sponsor ID
- 199826
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 5 Sep 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.
Patients with poor heart function can, in certain situations, have a further weakening of the heart muscle such that it becomes difficult to provide enough blood to the brain and other organs. In these cases, heart function can be supported by the use of medicines or heart pumps. One of the most widely used medicines is Dobutamine, given as an infusion (a drip). Although Dobutamine has been in use for decades and does improve blood flow to the organs, previous studies have not shown any impact on recovery of heart muscle function and survival. Key to unravelling this discrepancy is to understand the precise effects of Dobutamine on the oxygen supply to, and oxygen usage by, the heart muscle. We also aim to find out whether simultaneous infusion of another drug called Nitrite (naturally occurring substance that is found in beetroot for example, much like GTN) can enhance the beneficial effects of Dobutamine on the oxygen supply-demand balance of the heart. In recent years, major advances in technology mean that it is now possible to obtain this information in patients undergoing coronary angiography procedures by making detailed measurements of heart muscle function and blood flow in the heart arteries using a conductance catheter (measures volume and pressure within the main pumping chamber of the heart) and the Combowire (dual pressure and flow sensor tip angioplasty guidewire). The aim of this study is to understand the effect of a brief infusion of Dobutamine and nitrite on heart muscle function, oxygen supply and oxygen usage through this use of this technology, directly following the patients routine coronary angiogram. Patients will have these measurements taken using the technology described above during the infusion of both dobutamine and nitrite, inserted through blood vessels that reach the heart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for diagnostic coronary angiography following a diagnosis of heart failure, with a left ventricular ejection fraction of less than or equal to 40%.
Key inclusion criteria (3 listed)
- Left Ventricular Ejection Fraction <40%
- Patients aged >18 years
- Able to provide written consent
Key exclusion criteria (3 listed)
- Known acquired or congenital structural heart disease such as severe valve disease, ventricular/atrial septal defects
- Haemodynamic Instability
- Severe disease in major proximal coronary arteries or planned percutaneous coronary intervention during the index procedure
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 |
|---|---|---|
| DobutamineDobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter. | Drug | – |
| NitriteNitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter. | Drug | – |
Primary outcome
Coronary Flow (average peak velocity)
Time frame: During procedure.
left ventricular stroke work
Time frame: during procedure
7 secondary outcomes
rate pressure product
Time frame: during procedure
pressure volume area
Time frame: during procedure
coronary microvascular resistance
Time frame: during procedure
stroke volume
Time frame: during procedure
Distal tissue perfusion
Time frame: during procedure
Magnitude of forward compression wave
Time frame: during procedure
magnitude of backward expansion wave
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- 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.
British Heart Foundation Centre of Excellence, The Rayne Institute, KCL, at Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
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, run by King's 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Flow (average peak velocity) (time frame: During procedure.). The study lists 2 primary outcomes in all. 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 5 Sep 2016.