Dietary Nitrates for Heart Failure (BRJ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01682356
First received: September 5, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine if nitrates in a food, in this case - beetroot juice (BRJ) - is efficacious in improving exercise tolerance and/or peak power in patients with heart failure (a condition in which the heart muscle is weak and does not adequately pump blood to the body). The investigators will also determine if BRJ improves blood pressure, exercise efficiency, vascular and muscle function. The investigators will also determine if blood levels of nitrates increase after BRJ ingestion. To this end, the investigators will enroll study subjects with heart failure and give them a specified amount of BRJ (or placebo - a similar drink without nitrates) and measure the above-listed items. Then after a 10 day wash-out period (a time when they are not given BRJ or placebo)they will be switched and given either the BRJ or the placebo (whichever they did not receive the first time) and the tests will be repeated.

A secondary aim is to determine if BRJ-derived nitrates are still effective at 1 and 2 weeks after starting treatment. The investigators will determine if BRJ improves blood pressure, exercise efficiency, and muscle function at 1- and 2-weeks after starting BRJ (1 dose/day). The investigators will also determine if blood levels of nitrates increase after BRJ ingestion at 1 and 2 weeks after starting therapy. A tertiary aim is to determine the variation in the 6 minute walk test. Subjects will answer a basic medical information sheet and undergo a 6-minute walk test. After at least a 48 h rest, subjects will be asked to repeat the 6 min walk.

The investigators will also determine if BRJ (as compared to placebo) improves peak power output in heart failure patients and controls.

The investigators will also determine if BRJ decreases elevated pulmonary artery (PA) pressures or improves vascular and/or microvascular function in patients who are already coming in for a PA catheter placement for clinical purposes.

The investigators will also compare the physiological changes after BRJ ingestion in non heart failure control subjects with those of patients with heart failure.

The investigators hypothesize that patients with heart failure and controls will have improved exercise capacity and power at lower oxygen cost (and thereby greater efficiency) after ingesting beet juice (BRJ) than after ingesting placebo (beet juice without nitrates). The investigators hypothesize that patients with heart failure will have a greater physiologic response to BRJ than non heart failure controls since the former have worse physiological function to start with. The investigators hypothesize that patients with high pulmonary artery pressures will have an improvement in the pressures after ingestion with BRJ.


Condition Intervention Phase
Heart Failure
Hypertension, Pulmonary
Biological: Beetroot Juice (BRJ) a botanical
Biological: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Nitrates for Heart Failure

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 6 minute walk test [ Time Frame: each person is tested over a maximum of a 2 week intervention ] [ Designated as safety issue: No ]
    Patients in the main study undergo a 6 minute walk test (submaximal exercise tolerance) after ingesting BRJ or placebo. Then the subject undergoes a 10 d wash-out period and is on a low-nitrate diet and then ingests either the BRJ or the placebo (whichever he/she has not already ingested) and the 6 min walk test is repeated


Secondary Outcome Measures:
  • VO2 peak [ Time Frame: each subject is tested over a maximum of a 2 week period ] [ Designated as safety issue: No ]
    Each subject performs a VO2 test after ingesting BRJ or placebo. There is a 10 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).

  • Peak power [ Time Frame: each subject is tested at maximum over a 2 week period ] [ Designated as safety issue: No ]
    Each subject performs a neuromuscular power test after ingesting BRJ or placebo. There is a 10 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).

  • pulmonary artery pressure [ Time Frame: 1 day intervention ] [ Designated as safety issue: Yes ]
    Each patient who is going to have a PA catheter placed for clinical purposes will have their PA pressures measured before and after ingestion of BRJ.

  • Cardiac function [ Time Frame: after ingestion of BRJ or placebo ] [ Designated as safety issue: No ]
    Subjects undergoing MRI or echocardiography will have various measures of cardiac function made


Other Outcome Measures:
  • blood pressure [ Time Frame: each subject is tested at a maximum of over a ~ 2week period ] [ Designated as safety issue: Yes ]
    Each subject undergoes blood pressure checks after ingesting BRJ or placebo. There is a 10 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).

  • vascular function [ Time Frame: each patient will undergo a study for a maximum of ~ 2 weeks ] [ Designated as safety issue: No ]
    Each subject undergoes a laser Doppler test and a brachial artery test after ingesting BRJ or placebo. There is a 10 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).

  • Nitric oxide and nitrate and nitrite [ Time Frame: before and after BRJ or placebo ingestion ] [ Designated as safety issue: No ]
    We will measure nitric oxide, nitrate and nitrite before and after ingestion of BRJ or placebo


Estimated Enrollment: 126
Study Start Date: January 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BRJ crossover to placebo
BRJ without nitrates
Biological: placebo
Experimental: BRJ
Beetroot Juice with nitrates
Biological: Beetroot Juice (BRJ) a botanical
double-blind placebo-controlled cross-over study
Other Names:
  • Beet juice
  • Beet It

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women will have a history of heart failure (and/or pulmonary hypertension for PA catheter substudy).
  • Age > or = 21 y and controls of the same age range without heart failure.

Exclusion Criteria:

  • Age < 21 y.
  • Those taking phosphodiesterase inhibitors (e.g., Viagra) will be excluded, as these can potentiate NO effects.
  • Those taking proton pump inhibitors, antacids, or xanthine oxidase inhibitors will be excluded as these can affect reduction of nitrate (NO3-) and nitrite (NO2-) to nitric oxide (NO).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682356

Contacts
Contact: Marsha Farmer, MS 314-747-3357 mfarmer@dom.wustl.edu
Contact: Linda R. Peterson, MD 314-362-4577 lpeterso@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Marsha Farmer, MS    314-747-3357    mfarmer@dom.wustl.edu   
Contact: Linda R Peterson, MD    314-362-4577    lpeterso@dom.wustl.edu   
Principal Investigator: Linda R Peterson, MD         
Sub-Investigator: Andrew R Coggan, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: Linda R Peterson, MD Washington University School of Medicine
Study Director: Andrew R Coggan, PhD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01682356     History of Changes
Other Study ID Numbers: BRJ_201111134
Study First Received: September 5, 2012
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
heart failure
hypertension, pulmonary
oxygen consumption
exercise tolerance

Additional relevant MeSH terms:
Heart Failure
Hypertension
Hypertension, Pulmonary
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014