A Phase 1/2 interventional study of nicotinamide riboside and Placebo in Heart Failure, Systolic, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by University of Washington · Phase 1/2, Interventional, and Other
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 41st largest by enrollment of the 69 interventional ones that give a count, is one of 9 that started in 2016, is one of 4 in phase 1/2, and was the 25th registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 9 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 83 have an industry lead sponsor. The 10 most frequent:
University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
University of Washington has 2 studies filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
Add all 7 to your calendar (.ics) → With an account.
Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Mitochondrial dysfunction has been implicated in heart failure (HF), and is associated with an imbalance in intracellular ratio of reduced nicotinamide-adenine dinucleotide (NADH) to oxidized nicotinamide-adenine dinucleotide (NAD), or the NADH/NAD ratio. In mouse models of HF, we have found that normalization of the NADH/NAD, through supplementation with NAD+ precursors, is associated with improvement in cardiac function. This Study will randomize participants with systolic HF (ejection fraction ≤40%) to treatment with the NAD precursor, nicotinamide riboside (NR) or matching placebo, uptitrated to a final oral dose of 1000mg twice daily, to determine the safety and tolerability of NR in participants with systolic HF.
Aim 1: Determine the safety and tolerability of NR in patients with clinically stable, systolic heart failure (LVEF \<40%). To accomplish this Aim:
A) a total of 30 participants with clinically stable, systolic heart failure (LVEF \<40%) will undergo 2:1 randomization to NR 250mg PO twice daily or matching placebo B) NR (or matching placebo), will be increased weekly by 250mg/dose (500mg/day) to a final dose of 1000mg PO twice daily. Clinic visits with labs bi-weekly during dose escalation will assess HF symptoms and monitor labs [B-type natriuretic peptide (BNP), complete blood count (CBC), glycosylated hemoglobin, alanine aminotransferase (ALT), creatine kinase (CK), insulin/glucose, uric acid, electrolytes, blood urea nitrogen (BUN) and creatinine (Cr).
C) to ensure intermediate-term safety and tolerability, participants will continue on their maximum tolerated dose (of NR or placebo) through Study Week 12
Aim 2: Determine whether, at the doses employed, NR and NAD are detectable in whole blood.
Aim 3 (Exploratory): Assess the range of potential effect sizes of NR on HF surrogate endpoints using:
A) Six-minute walk tests (6MWTs) at each visit (including Screening) to assess functional capacity B) Echocardiography at Baseline and Week 12 to assess LV systolic function (by real-time, 3D echocardiography) and diastolic function (by integrated Doppler and tissue Doppler imaging)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nicotinamide riboside will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Dietary Supplement: nicotinamide riboside
Matching placebo will be supplied as 250mg capsules, to be administered orally. The initial dose will be 1 capsule twice daily, followed by weekly up-titration by 1 capsule/dose to a final dose of 4 capsules (1000mg) twice daily at the end of Week 4. Participants will be continued on the final dose up to the final follow up visit (week 12). If, at any step, a dose increase is not tolerated, the maximum previously-tolerated dose will be continued through to week 12.
Drug: Placebo
nicotinamide riboside capsule
Also known as: Niagen
matching placebo capsule
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse Events
Time frame: up to 12 weeks
On-Trial Change in Whole Blood NAD+ Levels
Between-group comparison of On-Trial Change in Whole Blood NAD+ Levels
Time frame: Week 12-Week 0
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Incidence of On-Trial Abnormal Laboratory Values and/or Adverse Events that Are Related to Treatment
Time frame: 16 weeks
Effect of NR on Change in Mitochondrial Function (Maximal Oxygen Consumption Rate)
Mitochondrial Respiration in Isolated Peripheral Blood Mononuclear Cells by the Seahorse (R) Assay
Time frame: Week 12 - Week 0
Exploratory Endpoint: Effect of NR on Functional Capacity
Change in Six Minute Walk Distance
Time frame: Week 12 - Week 0
Exploratory Endpoint: Effect of NR on Change in Left Ventricular Systolic Function
Change in Left Ventricular Ejection Fraction by 3D-Transthoracic Echocardiography
Time frame: Week 12 - Week 0
Exploratory Endpoint: Effect of NR on Left Ventricular Diastolic Function
Tissue Doppler Imaging, e'
Time frame: Week 12 - Week 0
| Milestone | Nicotinamide Riboside | Placebo |
|---|---|---|
| Started | 20 | 10 |
| Completed | 20 | 10 |
| Not completed | 0 | 0 |
Adverse Events
| events/participant | Nicotinamide Riboside | Placebo |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | 3.1 (0.0 to 9.0) | 3.2 (1.0 to 7.0) |
Between-group comparison of On-Trial Change in Whole Blood NAD+ Levels
| uM | Nicotinamide Riboside | Placebo |
|---|---|---|
| On-Trial Change in Whole Blood NAD+ Levels | 29.0 ± 3.2 | -0.3 ± 0.6 |
Incidence of On-Trial Abnormal Laboratory Values and/or Adverse Events that Are Related to Treatment
| participants | Nicotinamide Riboside | Placebo |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 0 | 0 |
Mitochondrial Respiration in Isolated Peripheral Blood Mononuclear Cells by the Seahorse (R) Assay
| pmol/min/1,000,000 cells | Nicotinamide Riboside | Placebo |
|---|---|---|
| Effect of NR on Change in Mitochondrial Function (Maximal Oxygen Consumption Rate) | 21 ± 42 | 2 ± 23 |
Change in Six Minute Walk Distance
| meters | Nicotinamide Riboside | Placebo |
|---|---|---|
| Exploratory Endpoint: Effect of NR on Functional Capacity | 6 ± 8 | 1 ± 15 |
Change in Left Ventricular Ejection Fraction by 3D-Transthoracic Echocardiography
| percentage of ejection fraction | Nicotinamide Riboside | Placebo |
|---|---|---|
| Exploratory Endpoint: Effect of NR on Change in Left Ventricular Systolic Function | 0.0 ± 2.2 | 0.3 ± 2.2 |
Tissue Doppler Imaging, e'
| cm/sec | Nicotinamide Riboside | Placebo |
|---|---|---|
| Exploratory Endpoint: Effect of NR on Left Ventricular Diastolic Function | 0.37 ± 0.54 | -0.44 ± 0.39 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nicotinamide Riboside | 0/20 (0%) | 1/20 (5%) | 19/20 (95%) |
| Placebo | 0/10 (0%) | 2/10 (20%) | 9/10 (90%) |
| Event | Nicotinamide Riboside | Placebo |
|---|---|---|
| Acute pulmonary edemaRespiratory, thoracic and mediastinal disorders | 0/20 | 1/10 |
| Heart failureCardiac disorders | 0/20 | 1/10 |
| Myalgia, severeMusculoskeletal and connective tissue disorders | 1/20 | 0/10 |
| Event | Nicotinamide Riboside | Placebo |
|---|---|---|
| Nervous system disordersNervous system disorders | 6/20 | 5/10 |
| Infections and infestationsInfections and infestations | 6/20 | 5/10 |
| General disorders and administration site conditionsGeneral disorders | 9/20 | 4/10 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 3/20 | 3/10 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 5/20 | 1/10 |
| Gastrointestinal disordersGastrointestinal disorders | 3/20 | 2/10 |
| Cardiac disordersCardiac disorders | 3/20 | 1/10 |
| Renal and urinary disordersRenal and urinary disorders | 1/20 | 1/10 |
| Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 1/20 | 1/10 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 2/20 | 1/10 |
| Age, Continuous(years) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Mean | 58 (37 to 81) | 60 (39 to 76) | 59 (37 to 81) |
| Sex: Female, Male(Participants) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 15 | 8 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 19 | 9 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 17 | 10 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| United States | 20 | 10 | 30 |
| Sitting Blood Pressure Systolic(mmHg) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Mean | 106 (65 to 139) | 106 (96 to 122) | 106 (65 to 139) |
| Sitting Blood Pressure Diastolic(mmHg) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Mean | 67 (45 to 104) | 64 (58 to 68) | 66 (45 to 104) |
| Heart rate(beats/min) | Nicotinamide Riboside | Placebo | Total |
|---|---|---|---|
| Mean | 67 (42 to 84) | 66 (55 to 80) | 67 (45 to 84) |
29 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — A de-identified, public access database will be made available two years after publication of the primary study results. Data files will be delivered in electronic format, providing meta-data that completely describes the tables, variables and coding. Both the raw data and the primary analysis files will be included. Primary analysis files are a compilation of key variables used to generate the statistical results, to help assure that investigators reach consistent conclusions when analyzing the data to published results. Data, documentation and all other materials will be delivered to NHLBI, as well as a document that fully describes the data, steps taken to de-identify the data, and quality control procedures. A document summarizing data tables and other files that are being delivered and describing the data manipulations applied to the data to assure data anonymity, including an annotated clinical study report providing the database variable names.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 2 years following Study completion
Ran from May 2016 to primary completion in Apr 2019, 34 months.
Results were first posted in Nov 2022, 3 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicotinamide-beta-riboside