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NCT01682356 · ClinicalTrials.gov registry record · Phase 1

Dietary Nitrate for Heart Failure

A Phase 1 study of Heart Failure and Hypertension, Pulmonary, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
2
Study locations

NCT01682356 is a Phase 1 study of Heart Failure and Hypertension, Pulmonary that has completed, run by Washington University School of Medicine. The registered enrollment target is 17 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01682356, a Phase 1 study of Heart Failure and Hypertension, Pulmonary, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
2
Study locations

Study 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 r

Conditions Studied

Heart Failure Hypertension, Pulmonary

Interventions

  • DIETARY_SUPPLEMENT Beetroot juice

Study Locations (2)

Indiana

  • Indiana University Purdue University Indianapolis - Indianapolis

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2012-01
Est. Completion 2023-07-01
Phase Phase 1

Sponsor

Washington University School of Medicine

1,502 total trials

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What the Registry Record Tells You About NCT01682356

The ClinicalTrials.gov registry entry for NCT01682356 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Beetroot juice is the first listed.

NCT01682356 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Indiana, Missouri.

Frequently Asked Questions

What is clinical trial NCT01682356 about?

NCT01682356 is a clinical study titled "Dietary Nitrate for Heart Failure". 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 ...

What is the current status of trial NCT01682356?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-01. Estimated completion is 2023-07-01.

What conditions does trial NCT01682356 study?

This clinical trial studies the following conditions: Heart Failure, Hypertension, Pulmonary.

What interventions are being tested in trial NCT01682356?

The interventions under investigation include: Beetroot juice (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01682356?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01682356 being conducted?

This trial has 2 study locations across Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.