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Matching Perfusion and Metabolic Activity in HFpEF

Plain-language guide to NCT04913805: phase 2 randomized trial of NAD+ and L-Carnitine, 53 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04913805
Phase
phase 2
Status
recruiting participants
Start
2021-10-11
Completion (planned or actual)
2027-05-01
Participants
53 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Heart Failure With Preserved Ejection Fraction
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around NAD+ and L-Carnitine.

It had three arms (groups): Potassium Nitrate (active comparator), Potassium Nitrate + Propionyl-L-Carnitine + Nicotinamide Riboside (active comparator) and Potassium Chloride (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 53 planned participants were the target.

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: NYHA Class II-III symptoms. Stable medical condition for at least 2 weeks, as per investigator judgment. Prior or current evidence for elevated filling pressures as follows:.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: age \<18 years old; treatment with organic nitrates or phosphodiesterase inhibitors that cannot be interrupted; uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment.

How the Study Was Run

The set-up was randomized, crossover and quadruple-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.

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

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 2021-10-11 with completion listed for 2027-05-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Submaximal Exercise Endurance (time frame: week 6).

It also tracked 7 secondary outcomes, for example Skeletal muscle oxidative capacity, Vasodilatory Reserve, Kansas City Cardiomyopathy Questionnaire Overall Summary Score, VO2 Kinetics, Peak VO2 and Steps per day.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ and L-Carnitine in 53 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page and the L-Carnitine compound page, all human trials.

Our Notes on the Compounds

NAD+: The coenzyme that accepts electrons at complex I.

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

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.