Effects of Dietary Nitrate Supplementation on Cardiorespiratory Control in Chronic Heart Failure

NCT02401126 | Completed Phase 4

• 1 other identifier: 6012610
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to determine whether dietary nitrate supplementation via concentrated beetroot juice improves central and peripheral cardiovascular control and physical capacity in patients with systolic heart failure.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  Cycle ergometer exercise test to the limit of tolerance

  8 days

Secondary Outcomes (7)

• Plasma nitrate and nitrite concentrations

  8 days

• Central and peripheral fatigue

  8 days

• Skeletal muscle and cerebral blood flow and oxygenation

  8 days

• Neuromuscular activity

  8 days

• Dyspnea and leg effort scores

  8 days

Study Arms (2)

Nitrate supplementation

ACTIVE COMPARATOR

Concentrated nitrate-rich beetroot juice

Dietary Supplement: Nitrate supplementation

Placebo

PLACEBO COMPARATOR

Nitrate-depleted beetroot juice

Dietary Supplement: Placebo

Interventions

Nitrate supplementation DIETARY_SUPPLEMENT

Nitrate supplementation: concentrated nitrate-rich beetroot juice (2 x 70 ml/day; approximately 10 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days.

Also known as: Concentrated nitrate-rich beetroot juice

Nitrate supplementation

Placebo DIETARY_SUPPLEMENT

Placebo: nitrate-depleted beetroot juice (2 x 70 ml/day; approximately 0.01 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days. The placebo juice is similar to the concentrated beetroot juice in appearance, texture, smell and taste and is obtained by removing nitrate ions from the latter.

Also known as: Nitrate-depleted beetroot juice

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- previous diagnosis of systolic heart failure (left ventricular ejection fraction \<40%) under optimized clinical treatment as judged by the accompanying physician.

You may not qualify if:

• hospital admission in the previous 6 weeks;
• exercise training program in the previous 6 months;
• nitrate therapy (e.g., isosorbide dinitrate);
• tabagism;
• any condition that could interfere with the ability to exercise;
• diagnosed psychiatric or cognitive disorders;
• type I insulin-dependent diabetes mellitus;
• excessively over-weight (BMI\>35kg/m²);
• other diagnosed cardiorespiratory disorders (e.g., chronic obstructive pulmonary disease, peripheral artery disease).

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• J. Alberto Neder, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04