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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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:     Brodie L Loudon, MBBS
Address: 
Telephone: 44(0) 1603 591 216
Email: b.loudon@uea.ac.uk
Affiliation: 
Name:     Brodie L Loudon, MBBS
Address: 
Telephone: 44(0) 1603 591 216
Email: b.loudon@uea.ac.uk
Affiliation: 
Name:     Sunil V Nair, MD
Address: 
Telephone:
Email:
Affiliation:  Norfolk and Norwich University Hospitals NHS Foundation Trust
Name:     Michael P Frenneaux, MD
Address: 
Telephone:
Email:
Affiliation:  University of East Anglia
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)
Diagnostic Test: Exercise Stress Transthoracic Echocardiogram
Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy
Drug: Placebo
Drug: Sodium Nitrate
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)
British Medical Research Council
Norfolk and Norwich University Hospitals NHS Foundation Trust
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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