Trials Sponsors Conditions Drugs Pricing

Brief Summary

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.

Conditions

Heart Failure Hypertension, Pulmonary

Keywords

heart failurehypertension, pulmonaryoxygen consumptionexercise tolerance

Outcome Measures

Primary Outcomes (1)

Maximal Knee Extensor Power
Maximal power of the quadriceps muscle group as measured using isokinetic dynamometry
2-3 h after acute dose of beetroot juice containing or essentially devoid of nitrate

Secondary Outcomes (1)

VO2peak
2-3 h after acute dose of beetroot juice containing or essentially devoid of nitrate

Other Outcomes (25)

Baseline Plasma Nitrate
0 h
Plasma Nitrate @ 1 h
1 h
Plasma Nitrate @ 2 h
2 h
+22 more other outcomes

Study Arms (2)

Beetroot juice without nitrate

PLACEBO COMPARATOR

Patients will be studied before and after ingestion of beetroot juice without nitrate

Dietary Supplement: Beetroot juice

Beetroot juice with nitrate

ACTIVE COMPARATOR

Patients will be studied before and after ingestion of beetroot juice with nitrate.

Dietary Supplement: Beetroot juice

Interventions

Beetroot juiceDietary supplement

double-blind placebo-controlled cross-over study

Also known as: Beet It

Beetroot juice with nitrateBeetroot juice without nitrate

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Sponsors & Collaborators

Washington University School of Medicine
Otherlead
The Foundation for Barnes-Jewish Hospital
Othercollaborator

Study Sites (2)

Indiana University Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Related Publications (11)

Masschelein E, Van Thienen R, Wang X, Van Schepdael A, Thomis M, Hespel P. Dietary nitrate improves muscle but not cerebral oxygenation status during exercise in hypoxia. J Appl Physiol (1985). 2012 Sep 1;113(5):736-45. doi: 10.1152/japplphysiol.01253.2011. Epub 2012 Jul 5.
PMID: 22773768BACKGROUND
Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
PMID: 22414688BACKGROUND

MeSH Terms

Conditions

Heart FailureHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular Diseases

Limitations and Caveats

Due to restrictions on research resulting from the COVID-19 pandemic, many outcome measures/planned substudies were not completed.

Results Point of Contact

Title: Linda R. Peterson, MD
Organization: Washington University School of Medicine

Study Officials

Linda R Peterson, MD
Washington University School of Medicine
PRINCIPAL INVESTIGATOR
Andrew R Coggan, PhD
Indiana University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

17 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Dietary Nitrate for Heart Failure

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (25)

Study Arms (2)

Beetroot juice without nitrate

Beetroot juice with nitrate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations