Effect of Dietary Nitrate Ingestion in Heart Failure

NCT03511248 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-03

No results posted yet for this study

Summary

This study evaluates the addition of inorganic dietary nitrate to the optimal treatment of patients diagnosed with heart failure with reduced ejection fraction. Some vegetables contain large amounts of inorganic nitrate, and research suggests that this nitrate has beneficial effects on the heart and blood vessels. We have shown in lab experiments that nitrate has positive effects on the heart. We wish to test whether dietary nitrate might be useful in halting deterioration and/or improving heart function in patients with heart failure, with a specific focus on a marker of poor outcome in heart failure: high uric acid levels. Half of the patients will receive nitrate-rich beetroot juice, and the other half a nitrate-deplete placebo beetroot juice.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nitrate-rich Beetroot Juice

The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day.

DIETARY_SUPPLEMENT

Nitrate-deplete Beetroot Juice

The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day.

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Dr Simon Woldman, MD FRCP FESC · Fellow of the Royal College of Physicians and Fellow of the European Society of Cardiology

  • Dr Ceri Davies, MD FRCP FESC · Fellow of the Royal College of Physicians and Fellow of the European Society of Cardiology

  • Prof Amrita Ahluwalia, BSc PhD · William Harvey Research Institute, Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2025-01-07
Completion
2025-01-07

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511248 on ClinicalTrials.gov