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NCT02457260 · ClinicalTrials.gov registry record · Phase 2
Oral Nitrite for Older Heart Failure Patients
A Phase 2 study of Heart Failure, sponsored by Gladwin, Mark, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02457260 is a Phase 2 study of Heart Failure that has completed, run by Gladwin, Mark, MD. The registered enrollment target is 21 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02457260, a Phase 2 study of Heart Failure, has completed, sponsored by Gladwin, Mark, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved sodium nitrite (10 milligram \[mg\]) capsule, and its utility to upregulate the sirtuin 3 adenosine monophosphate protein kinase (SIRT3-AMP) pathway of skeletal muscle of younger heart failure (HF) patients. It now seems exceptionally logical and opportune to apply these insights to older HF patients and to delineate mechanisms of disease and aging that respond to nitrite therapy.
Conditions Studied
Interventions
- DRUG 14 N Sodium Nitrite
Study Locations (1)
Pennsylvania
- UPMC Montefiore Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-01-08 |
| Est. Completion | 2017-03-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02457260
The ClinicalTrials.gov registry entry for NCT02457260 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 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 Gladwin, Mark, MD, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which 14 N Sodium Nitrite is the first listed.
NCT02457260 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02457260 about?
NCT02457260 is a clinical study titled "Oral Nitrite for Older Heart Failure Patients". Studies have demonstrated nitrite therapy increases adenosine triphosphate (ATP) synthesis in skeletal muscle mitochondria concomitant with reduced whole-body oxygen cost during steady state exercise. Our own work has demonstrated safety and efficacy of an FDA investigational new drug (IND) approved...
What is the current status of trial NCT02457260?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2016-01-08. Estimated completion is 2017-03-06.
What conditions does trial NCT02457260 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT02457260?
The interventions under investigation include: 14 N Sodium Nitrite (DRUG).
Who is sponsoring clinical trial NCT02457260?
This trial is sponsored by Gladwin, Mark, MD, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02457260 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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