Randomised double blinded controlled pilot trial investigating the effect dietary nitrate in the treatment of acute decompensated heart failure.

Phase 2

Withdrawn

• Conditions: Heart Failure; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000689774
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 18-75 years
Acute decompensated HF requiring hospitalization (at the discretion of the treating physician), reflected by clinical signs or symptoms of peripheral or pulmonary congestion
NYHAC III or IV
And LVEF less than 40% (either previously documented or documented at admission)

Exclusion Criteria

Age between 18, and 75
Hypotension (BP less than 90)
inotropic therapy
anticipated need for LVAD or ECMO within 48 hrs
endotracheal intubation/ventilation
cardiac or other solid organ transplantation
STEMI at presentation
suspected sepsis
arrhyhthmia as a primary cause for ADHF
Allergy to Beetroot
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary hypothesis in this study is that dietary nitrate supplementation will improve vascular function in ADHF patients.<br><br>Assessment of outcome - improvement in symptoms via KCCQ, Endopat tool to assess vascular function, [Day 5]

Secondary Outcome Measures

Name	Time	Method
The secondary end point is overall ‘treatment success’ . This composite parameter has been widely used in HF trials. Outcomes are defined as ‘treatment success’, treatment failure, or no change in the patient’s condition. Success is defined as patient-reported moderate or marked improvement in dyspnoea at 5 days, in the absence of any criterion for failure. [Day 5]