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NCT02797184 · ClinicalTrials.gov registry record · Phase 1
Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response
A Phase 1 study of Heart Failure, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02797184: Completed Phase 1 study of Heart Failure, sponsored by Washington University School of Medicine.
NCT02797184 is a Phase 1 study of Heart Failure that has completed, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02797184, a Phase 1 study of Heart Failure, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to do the work that is necessary and sufficient for setting up an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart failure: inorganic nitrate. The investigators will first determine the effects and palatability of \~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount of nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format) on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise performance in a dose-response study. Third, the investigators will perform a small phase II chronic treatment study that will allow them to determine the best primary endpoint and the numbers of patients the investigators will need to study in the large, multi-center RCT to follow this project. In the small study and in the RCT to follow, the investigators will determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and speed of muscle contraction, and lessen the effort of breathing during exercise.
Primary Outcome
peak oxygen consumption during treadmill exercise
Conditions Studied
Interventions
- DRUG KNO3, potassium nitrate
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 1 |
What the finished NCT02797184 record still lists
NCT02797184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which KNO3, potassium nitrate is the first listed.
NCT02797184 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02797184 about?
NCT02797184 is a clinical study titled "Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response". The purpose of this study is to do the work that is necessary and sufficient for setting up an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart failure: inorganic nitrate. The investigators will first determine the effects and palatability of \~12.8mmol KNO3 (an o...
What is the current status of trial NCT02797184?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2017-10-31. Estimated completion is 2021-12-15.
What conditions does trial NCT02797184 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT02797184?
The interventions under investigation include: KNO3, potassium nitrate (DRUG).
Who is sponsoring clinical trial NCT02797184?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02797184 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02797184's enrollment target sits among peer trials
42 302nd of 397 higher than 94 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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