PEDIatric Cardiac Dysfunction Treated With Injectable Nicotinamide Adenine Dinucleotide

What Was Tested

The trial (phase 2) is built around NAD+.

It had three arms (groups): Placebo Group (placebo comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Study design This is a multicenter, randomized, double-blind, placebo-controlled trial.

The total study duration is 24 months, and each participant will be involved for approximately 48 weeks (7-day treatment period + 48-week follow-up period).

A stratified block randomization method (block length of 6) will be used, with stratification by center.

Each center will have an independent randomization stratification.

Who Took Part

The registry lists 180 planned participants were the target.

It was open to people of any sex aged from 0 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \< 18 years.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: concomitant malignant arrhythmia; ischemic cardiomyopathy due to congenital or acquired coronary artery disease; cardiac dysfunction caused by systemic diseases (e.g., systemic lupus erythematosus, thyroid dysfunction); known allergy to coenzyme i; lactose intolerance or lactose allergy; history of severe allergy or infusion reaction.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-10-01 with completion listed for 2028-04-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to 4 Weeks (time frame: Baseline to 4 weeks after treatment).

It also tracked 12 secondary outcomes, for example Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) from Baseline, Change in LVEF from Baseline at Multiple Time Points, Change in Left Ventricular End-Diastolic Diameter (LVEDD) from Baseline, Change in Left Ventricular End-Systolic Diameter (LVESD) from Baseline, Change in Left Ventricular Wall Thickness from Baseline and Change in Pediatric Quality of Life Inventory (PedsQL) Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 180 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.