Trial · NCT07527481
Nortriptyline and the Risk of Serious Adverse Events
NCT07527481, Active not recruiting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nortriptyline and the Risk of Serious Adverse Events. Trials, record NCT07527481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07527481
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nortriptyline and the Risk of Serious Adverse Events
- NCT number
- NCT07527481
- Status
- Active not recruiting
- Enrollment
- 5,000 participants, actual
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Conditions
- Chronic Kidney Disease
- Interventions
- Nortriptyline Hydrochloride
- First posted
- 2026-04-14
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with a 30-day composite outcome of all-cause emergency department visit, all-cause hospitalization, or all-cause mortality. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | 30-day all-cause emergency department visit, all-cause hospitalization, and all-cause mortality will be combined into a composite measure. Only the first hospitalization or emergency department visit occurring after the cohort entry date will be considered. |
| Secondary | Number of participants with 30-day all-cause emergency department visit. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | One of the components of the primary composite outcome, 30-day all-cause emergency department visit, individually presented as a secondary outcome. Only the first 30-day emergency department visit after the cohort entry date will be considered. |
| Secondary | Number of participants with 30-day all-cause hospitalization. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | One of the components of the primary composite outcome, 30-day all-cause hospitalization, individually presented as a secondary outcome. Only the first 30-day hospitalization after the cohort entry date will be considered. |
| Secondary | Number of participants with 30-day all-cause mortality | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | One of the components of the primary composite outcome, 30-day all-cause mortality, individually presented as a secondary outcome. |
| Secondary | 30-day composite outcome of a hospital encounter with fragility fracture, falls, hypotension, or syncope. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | 30-day composite outcome of a hospital encounter (emergency department visit or hospital admission) with fragility fracture (hip, femur, humerus, wrist/forearm, pelvis, and spine), falls, hypotension, or syncope. |
| Secondary | 30-day hospital encounter composite of atrial fibrillation/flutter, ventricular arrhythmia/sudden cardiac death, and other arrhythmia. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | 30-day hospital encounter (emergency department visit or hospital admission) composite of atrial fibrillation/flutter, ventricular arrhythmia/sudden cardiac death, and other arrhythmia (including pacemaker insertion, palpitations, tachycardia unspecified, atrioventricular block, supraventricular tachycardia, other conduction disorders, implantable cardiac defibrillator). |
| Secondary | 30-day composite outcome of a hospital encounter with delirium or encephalopathy. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | 30-day composite outcome of a hospital encounter (emergency department visit or hospital admission) with delirium or encephalopathy (disorientation, transient alteration of awareness, and other unspecified symptoms and signs involving cognitive function) or hospital admission with receipt of an urgent computed tomography scan of the head. |
| Secondary | 30-day composite outcome of a hospital encounter with heart failure or myocardial infarction, or ischemic stroke. | Older adults exposed to high-dose (>10-150 mg/day) vs low-dose (10 mg/day) oral nortriptyline will enter the cohort and will be followed until study outcome (first event), death, or 30 days from the cohort entry date. | 30-day composite outcome of a hospital encounter (emergency department visit or hospital admission) with heart failure or myocardial infarction (most responsible diagnosis), or ischemic stroke (most responsible diagnosis). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07527481
GET https://conductscience.org/api/trials/v1/NCT07527481/registered