Nitrite in Hypertrophic Cardiomyopathy (HCM) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03251287
• Date of registration: 11/08/2017
• Prospective Registration: Yes
• Primary sponsor: University of East Anglia
• Public title: Nitrite in Hypertrophic Cardiomyopathy (HCM) Study
• Scientific title: Mechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic Cardiomyopathy
• Date of first enrolment: November 2017
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03251287
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Sunil V Nair, MD
• Affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust

• Name: Michael P Frenneaux, MD
• Affiliation: University of East Anglia

• Name: Brodie L Loudon, MBBS

• Name: Brodie L Loudon, MBBS

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cardiomyopathy, Hypertrophic

Intervention(s)

Drug: Placebo

Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy

Drug: Sodium Nitrate

Diagnostic Test: Exercise Stress Transthoracic Echocardiogram

Primary Outcome(s)

Cardiac Energetic Status [Time Frame: 3 hours post dose of drug or placebo]

Secondary Outcome(s)

Cardiac Diastolic and Systolic Function at rest [Time Frame: 3 hours post dose of drug or placebo]

Cardiac Diastolic and Systolic Function on exercise [Time Frame: 3 hours post dose of drug or placebo]

Plasma levels of Nitrate/Nitrite/NOx [Time Frame: 3 hours post dose of drug or placebo]

Skeletal Muscle Mitochondrial Oxidative Capacity/Energetic Status [Time Frame: 3.5 hours post dose of drug or placebo]

Secondary ID(s)

201323

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norfolk and Norwich University Hospitals NHS Foundation Trust

British Medical Research Council