Status:
UNKNOWN
Nitrite in Hypertrophic Cardiomyopathy (HCM) Study
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Norfolk and Norwich University Hospitals NHS Foundation Trust
British Medical Research Council
Conditions:
Cardiomyopathy, Hypertrophic
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Inorganic nitrate, which is found at high levels in green leafy vegetables, is reduced to nitrite by bacteria in the mouth, swallowed, and absorbed in the stomach into the blood. Studies have shown th...
Eligibility Criteria
Inclusion
- Male or female, aged between 18 and 80 years.
- 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
- Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcome.
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03251287
Start Date
November 1 2017
End Date
January 1 2019
Last Update
October 25 2017
Active Locations (1)
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1
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY