NCT03251287

Nitrite in Hypertrophic Cardiomyopathy (HCM) Study

Mechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic Cardiomyopathy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of East Anglia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 that increasing the blood levels of nitrite improves the way that muscles use oxygen and energy during exercise, and potentially blood flow. 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.

Conditions

• Cardiomyopathy, Hypertrophic

Interventions

Type	Name	Description
DRUG	Sodium Nitrate	Single dose of 14mmol oral inorganic sodium nitrate
DRUG	Placebo	Single dose of oral matching placebo
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2017-08-16
• Last updated: 2017-10-25

Locations

1 site across 1 country: United Kingdom