Trial · NCT02353312
Rhode Island Diastolic Dysfunction - Heart Failure
NCT02353312, Not applicable, Completed, Providence VA Medical Center; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rhode Island Diastolic Dysfunction - Heart Failure. Trials, record NCT02353312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02353312
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rhode Island Diastolic Dysfunction - Heart Failure
- NCT number
- NCT02353312
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 28 participants, actual
- Lead sponsor
- Providence VA Medical Center
- Conditions
- Heart Failure, Cardiovascular Disease
- Interventions
- Kuvan
- First posted
- 2015-02-02
- Last updated
- 2025-07-03
- Results first posted
- 2025-07-03
- Limitations and caveats
- Incomplete or missing data for only seven participants leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Oxygen Consumption During Maximal Bike Exercise | Baseline (period 0), 3 mos (period 1), 6 mos (period 2) | The change from baseline in oxygen consumption during maximal bike exercise. This was measured using cardiopulmonary exercise tress test (CPET), recorded in milliliters per kilogram per minute (mL/kg/min). Higher oxygen consumption scores indicate better aerobic capacity and cardiovascular function. An increase in oxygen consumption from baseline to post-intervention signifies an improvement in these areas. Conversely, a decrease would indicate a decline in aerobic capacity and cardiovascular health. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Oxygen Consumption During Maximal Bike Exercise | Baseline (period 0), 3 mos (period 1), 6 mos (period 2) | All patients who had both baseline and final test. | mL/kg/min | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Oxygen Consumption During Maximal Bike Exercise | On Kuvan | 14.45 | Standard Deviation 5.00 | mL/kg/min | |
| Change From Baseline in Oxygen Consumption During Maximal Bike Exercise | Not on Kuvan | 14.18 | Standard Deviation 3.69 | mL/kg/min |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Kuvan First, Then no Kuvan | 16 | |
| Overall Study | STARTED | No Kuvan First, Then Kuvan | 12 | |
| Overall Study | COMPLETED | Kuvan First, Then no Kuvan | 13 | |
| Overall Study | COMPLETED | No Kuvan First, Then Kuvan | 10 | |
| Overall Study | NOT COMPLETED | Kuvan First, Then no Kuvan | 3 | |
| Overall Study | NOT COMPLETED | No Kuvan First, Then Kuvan | 2 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fever | Infections and infestations | On Kuvan | 1 | 28 | 2 |
| other | Fever | Infections and infestations | Off Kuvan | 3 | 28 | 5 |
| other | Nausea | Gastrointestinal disorders | On Kuvan | 4 | 28 | 5 |
| other | Nausea | Gastrointestinal disorders | Off Kuvan | 2 | 28 | 3 |
| other | Emesis | Gastrointestinal disorders | On Kuvan | 0 | 28 | 0 |
| other | Emesis | Gastrointestinal disorders | Off Kuvan | 0 | 28 | 0 |
| other | Diarrhea | Gastrointestinal disorders | On Kuvan | 12 | 28 | 20 |
| other | Diarrhea | Gastrointestinal disorders | Off Kuvan | 8 | 28 | 17 |
| other | Rhinorrhea | Blood and lymphatic system disorders | On Kuvan | 14 | 28 | 17 |
| other | Rhinorrhea | Blood and lymphatic system disorders | Off Kuvan | 7 | 28 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | On Kuvan | 0 | 28 |
| Total, all-cause mortality | Off Kuvan | 0 | 28 |
| Total, other adverse events | On Kuvan | 28 | 28 |
| Total, other adverse events | Off Kuvan | 28 | 28 |
| Total, serious adverse events | On Kuvan | 4 | 28 |
| Total, serious adverse events | Off Kuvan | 6 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| On Kuvan vs Off Kuvan: deaths from any cause | Trial comparisons |
| On Kuvan vs Off Kuvan: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02353312
GET https://conductscience.org/api/trials/v1/NCT02353312/events?page=2