The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients suffering from chronic heart failure.

The Effects of Inorganic Nitrite on cardiac and skeletal muscle: Physiology, Pharmacology and Therapeutic Potential in patients with Chronic Heart Failure - Effects of Inorganic Nitrite on cardiac and skeletal muscle: CHF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000788-26-GB

Enrollment

Registered

2012-05-15

Start date

2012-06-18

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure

Interventions

Product Name: INORGANIC SODIUM NITRATE Pharmaceutical Form: Capsule INN or Proposed INN: Sodium Nitrate CAS Number: 7631-99-4 Concentration unit: mmol millimole(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who suffer from symptomatic but stable chronic heart failure despite maximal tolerated contemporary medication, of non-ischaemic aetiology, in sinus rhythm, will be recruited into the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: Patients will be excluded if: - they have been hospitalised for decompensated heart failure within the past three months - they have contra-indications for undergoing MRI

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome is Peak VO2O2 consumption/workload relation during submaximal exercise.;Secondary Objective: The secondary outcomes are the energy status of the heart by MRI, six-minute hall walk distance, plasma BNP, tissue Doppler E/EM,a Minessota Living with Heart Failure questionnaire, the effects of fibre type, metabolic enzyme expression/activity and proteomic changes at baseline and after treatment respectively.;Primary end point(s): Peak VO2O2 consumption/workload relation during submaximal exercise.;Timepoint(s) of evaluation of this end point: At baseline and after three months of treatment.	—

Measure

Time frame

Main Objective: The primary outcome is Peak VO2O2 consumption/workload relation during submaximal exercise.;Secondary Objective: The secondary outcomes are the energy status of the heart by MRI, six-minute hall walk distance, plasma BNP, tissue Doppler E/EM,a Minessota Living with Heart Failure questionnaire, the effects of fibre type, metabolic enzyme expression/activity and proteomic changes at baseline and after treatment respectively.;Primary end point(s): Peak VO2O2 consumption/workload relation during submaximal exercise.;Timepoint(s) of evaluation of this end point: At baseline and after three months of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Cardiac energetic status by MRI, six minute hall walk distance, a Minnesota Living with Heart Failure questionnaire, plasma N-terminal-BNP, Tissue Doppler E/Em (measure of LV diastolic pressure), the effects on fibre type, metabolic enzyme expression/activity and proteomic changes at baseline and after treatment respectively.;Timepoint(s) of evaluation of this end point: At baseline and after three months of treatment.	—

Measure

Time frame

Secondary end point(s): Cardiac energetic status by MRI, six minute hall walk distance, a Minnesota Living with Heart Failure questionnaire, plasma N-terminal-BNP, Tissue Doppler E/Em (measure of LV diastolic pressure), the effects on fibre type, metabolic enzyme expression/activity and proteomic changes at baseline and after treatment respectively.;Timepoint(s) of evaluation of this end point: At baseline and after three months of treatment.

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Countries

United Kingdom

Contacts

Public ContactHolland

g.holland@abdn.ac.uk01224437073

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026