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Nicotinamide Riboside in Systolic Heart Failure
Plain-language guide to NCT03423342: phase 1, phase 2 randomized trial of NAD+, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03423342
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2016-05-19
- Completion (planned or actual)
- 2019-04-11
- Participants
- 30 (actual)
- Design
- randomized, triple-blind, other
- Conditions studied
- Heart Failure, Systolic
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested NAD+.
It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).
The registry classes the interventions as dietary supplement and drug.
Who Took Part
30 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Clinically stable (no cardiac procedures or hospitalizations for hospitalizations for cardiac causes, including HF, ischemia or arrhythmia) within the previous 3 months. Willingness/ability to provide informed consent.
The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: cardiac surgery, percutaneous coronary intervention (pci) or cardiac device implantation within the previous 3 months; inability to perform study visits or procedures (e.g., physical inability to perform 6mwt); unwillingness/inability to provide informed consent.
How the Study Was Run
Design: randomized, single-group and triple-blind.
Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2016-05-19 with completion listed for 2019-04-11.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Primary outcome: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: up to 12 weeks).
It also tracked 3 secondary outcomes, for example Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment and Effect of NR on Change in Mitochondrial Function (Maximal Oxygen Consumption Rate).
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 30 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.