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Trial Outcomes & Findings for The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects (NCT NCT03565328)

NCT ID: NCT03565328

Last Updated: 2020-10-28

Results Overview

Number of participants who had enhancement mitochondrial function in skeletal muscle Nuclear magnetic resonance (NMR) spectroscopy will be performed at baseline, at the end of the 12-week Nicotinamide Riboside (NR) supplementation period and repeated 4 weeks post-NR washout.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

baseline-12 week-16 week

Results posted on

2020-10-28

Participant Flow

2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

Participant milestones

Participant milestones
Measure
Nicotinamide Riboside in Patients With Stable Heart Failure
Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nicotinamide Riboside in Patients With Stable Heart Failure
n=1 Participants
Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) then increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000 mg PO BID (2000 mg/day) in patients with stable, systolic heart failure.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline-12 week-16 week

Population: 2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

Number of participants who had enhancement mitochondrial function in skeletal muscle Nuclear magnetic resonance (NMR) spectroscopy will be performed at baseline, at the end of the 12-week Nicotinamide Riboside (NR) supplementation period and repeated 4 weeks post-NR washout.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 week

Population: 2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

Measure the effects in participants of Nicotinamide Riboside (NR) on oxidative phosphorylation and inflammation in respective subject primary skin fibroblasts

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 week

Population: 2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

To quantitative serum cytokine immunoassay profiling to assess whether Nicotinamide Riboside (NR) blunts heart failure (HF) linked inflammation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 week

Population: 2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

Serum quantitative metabolomic profiling, pre and post-cardiopulmonary exercise testing (CPET) to evaluate whether Nicotinamide Riboside (NR) increases the rate of oxidative phosphorylation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 week

Population: 2 participants signed informed consent: 1 subject completed the study; 1 subject failed the screening. Study was terminated due to lack of enrollment and precluded analysis of primary or secondary outcomes.

Analysis of VO2max and the anaerobic threshold will be measured.

Outcome measures

Outcome data not reported

Adverse Events

Nicotinamide Riboside in Patients With Stable Heart Failure

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Sack, M.D. Principal Investigator, NIH, NHLBI

National Heart Lung and Blood Institute (NHLBI)

Phone: 301.402.9259

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place