Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2017-11-30
2019-01-31
Brief Summary
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Some people (\~1 in 500) suffer from a type of genetic heart condition known as hypertrophic cardiomyopathy (HCM). This condition means that the muscle in the heart does not use energy well and becomes larger than average, meaning that they have to tap into the heart's 'energy reserves'. It is not known if nitrite has the same beneficial effects on heart muscle as on other muscles in the body. Our study will explore the mechanism by which nitrite may improve the function and energy status of the heart in HCM.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Sodium Nitrate
Following entry into the study, patients will receive a single dose of oral inorganic sodium nitrate (14mmol) on two separate visits, or matching placebo, in random order (i.e. 2x nitrate visits first or 2x placebo visits first) in a cross-over fashion.
Sodium Nitrate
Single dose of 14mmol oral inorganic sodium nitrate
Phosphorous Magnetic Resonance Spectroscopy
On the first visit day of this arm, participants will be lie inside an MRI scanner to take pictures of the heart. The thigh muscle will then be imaged before, during, and after kicking exercises.
Exercise Stress Transthoracic Echocardiogram
On the second visit day of this arm, participants will be asked to lie, semi-erect, on an exercise bed for up to 90 minutes. The echocardiogram will be performed at rest and during peak exercise. The exercise will be in the form of a pedal bike. The exercise levels will be worked out from an upright bicycle exercise test completed by the participants prior to randomization.
Placebo
Following entry into the study, patients will receive a single dose of oral inorganic sodium nitrate (14mmol) on two separate visits, or matching placebo, in random order (i.e. 2x nitrate visits first or 2x placebo visits first) in a cross-over fashion.
Placebo
Single dose of oral matching placebo
Phosphorous Magnetic Resonance Spectroscopy
On the first visit day of this arm, participants will be lie inside an MRI scanner to take pictures of the heart. The thigh muscle will then be imaged before, during, and after kicking exercises.
Exercise Stress Transthoracic Echocardiogram
On the second visit day of this arm, participants will be asked to lie, semi-erect, on an exercise bed for up to 90 minutes. The echocardiogram will be performed at rest and during peak exercise. The exercise will be in the form of a pedal bike. The exercise levels will be worked out from an upright bicycle exercise test completed by the participants prior to randomization.
Interventions
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Sodium Nitrate
Single dose of 14mmol oral inorganic sodium nitrate
Placebo
Single dose of oral matching placebo
Phosphorous Magnetic Resonance Spectroscopy
On the first visit day of this arm, participants will be lie inside an MRI scanner to take pictures of the heart. The thigh muscle will then be imaged before, during, and after kicking exercises.
Exercise Stress Transthoracic Echocardiogram
On the second visit day of this arm, participants will be asked to lie, semi-erect, on an exercise bed for up to 90 minutes. The echocardiogram will be performed at rest and during peak exercise. The exercise will be in the form of a pedal bike. The exercise levels will be worked out from an upright bicycle exercise test completed by the participants prior to randomization.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent.
* Able to understand basic instructions in English.
* A diagnosis of hypertrophic cardiomyopathy based on conventional transthoracic echocardiogram guidelines: left ventricular wall thickness \>1.5cm in the absence of sufficient alternative cause.
* Exercise limited by symptoms on exertion (NYHA Class II symptoms or greater).
* PeakVO2 \<80% on baseline CPEX.
* The absence of resting LV outflow tract obstruction (peak gradient \<30 mm Hg) on TTE.
Exclusion Criteria
* Contraindications for undergoing MRI.
* Hypotension with a systolic blood pressure \<90mmHg.
* Severe anaemia with a plasma haemoglobin level \<8.0g/dL.
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean decent.
* Female subjects of childbearing potential.
* Haemodynamically significant valve disease.
* Predisposed to acute on chronic limb ischemia evident from a history of claudication or known peripheral arterial disease.
18 Years
80 Years
ALL
No
Sponsors
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Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
British Medical Research Council
OTHER_GOV
University of East Anglia
OTHER
Responsible Party
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Principal Investigators
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Michael P Frenneaux, MD
Role: STUDY_CHAIR
University of East Anglia
Sunil V Nair, MD
Role: PRINCIPAL_INVESTIGATOR
Norfolk and Norwich University Hospitals NHS Foundation Trust
Locations
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Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Brodie L Loudon, MBBS
Role: primary
Other Identifiers
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201323
Identifier Type: -
Identifier Source: org_study_id