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

Phase 1

• Conditions: Chronic heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-000788-26-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-15
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.