Dietary Nitrates for Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 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: December 23, 2015
Last verified: December 2015
  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. The investigators will also determine if BRJ improves blood pressure, exercise efficiency, vascular and muscle function, and whether blood levels of nitrates increase hourly for a total of 4 hours after BRJ ingestion. A secondary aim is to determine if BRJ-derived nitrates are still effective at 1, 2 and 4 weeks after starting treatment. 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 hours rest, subjects will be asked to repeat the 6 minutes' walk. The investigators will (1) determine if BRJ (as compared to placebo) improves peak power output in heart failure patients and controls (at ~ 1½ to 2 hours after ingestion); (2) compare the changes in cardiac muscle (on average ~ 8-12 hours after) BRJ or placebo ingestion in patients who will be undergoing an left ventricle (LV) assist device placement for clinical purposes. (a cross-sectional study); (3) determine if BRJ decreases elevated pulmonary artery (PA) pressures or improves vascular and/or microvascular function (at ~ 1½ - 2 hours after ingestion) in patients who are already coming in for a PA catheter placement for clinical purposes; (4) compare the physiological changes after BRJ ingestion in non-heart failure control subjects with those of patients with heart failure. Endpoints measured at the same time points after ingestion. The investigators hypothesize (1) that patients with heart failure and controls will have improved exercise capacity and power at lower oxygen cost (and thereby greater efficiency) ~ 1½- 2 hours after ingesting beet juice (BRJ) than after ingesting placebo (beet juice without nitrates); (2) 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; (3) that patients with high pulmonary artery pressures will have an improvement in the pressures after ingestion with BRJ; (4) that myocardial perfusion will be higher after BRJ ingestion than after placebo; (5) that cyclic guanosine monophosphate (cGMP) levels will be increased in left ventricle assist device (LVAD) samples after BRJ ingestion compared with placebo.

Condition Intervention Phase
Heart Failure
Hypertension, Pulmonary
Dietary Supplement: Beetroot Juice (BRJ)
Dietary Supplement: 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:
  • Peak power [ Time Frame: each subject is tested at maximum over a 4 week period ] [ Designated as safety issue: No ]
    Each subject performs a neuromuscular power test after ingesting BRJ or placebo. There is a 7 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).


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 7 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

  • Myocardial perfusion [ Time Frame: before and after BRJ or placebo ingestion ] [ Designated as safety issue: No ]
    We will measure perfusion using noninvasive PET imaging

  • Myocardial tissue changes [ Time Frame: after BRJ or placebo ingestion ] [ Designated as safety issue: No ]
    We will measure cyclic GMP and nitrate in LV tissue after LVAD placement and after ingestion of either 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
Beetroot Juice without nitrate.s Patients will be studied before and after ingestion of beetroot juice
Dietary Supplement: placebo
double-blind placebo-controlled cross-over study
Active Comparator: Beetroot Juice
Beetroot Juice with nitrates. Patients will be studied before and after ingestion of beetroot juice with nitrates
Dietary Supplement: Beetroot Juice (BRJ)
double-blind placebo-controlled cross-over study
Other Names:
  • Beetroot juice
  • Beet It

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 = 18 y and controls of the same age range without heart failure.

Exclusion Criteria:

  • Age < 18 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: Dakkota Thies 314-747-3839 thiesd@mir.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: Dakkota Thies    314-747-3839    thiesd@mir.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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: December 23, 2015
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:
Hypertension
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 22, 2016