Trial · NCT03296813
TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
NCT03296813, Phase 3, Completed, Duke University; results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure. Trials, record NCT03296813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure
- NCT number
- NCT03296813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,973 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Heart Failure
- Interventions
- Torsemide, Furosemide
- First posted
- 2017-09-28
- Last updated
- 2025-10-16
- Results first posted
- 2025-10-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-cause Mortality, as Measured by Follow-up Phone Call or NDI | up to 30 months | Death information was obtained from the Call Center through 30 months for patients 1-500, through 24 months for patients 501-1000, through 18 months for patients 1001-1500, and through 12 months for the remaining patients (except those who were randomized \< 12 months when the study was stopped by the DSMB). Also death information was obtained through searches of the 2018-2021 National Death Index (NDI) database. |
| Secondary | All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | up to 12 months | The time-to-event analysis of all-cause mortality or all-cause primary re-hospitalization was based on the time from randomization through death or the first primary re-hospitalization through 12 months. Patients who died or whose first all-cause re-hospitalization was after month 12 were censored at month 12. Patients who did not have a re-hospitalization and were alive were censored at the minimum of the time of the last re-hospitalization assessment or month 12. |
| Secondary | Total Re-hospitalizations, as Measured by Follow-up Phone Call | up to 12 months | Total all-cause primary re-hospitalization was defined as a hospitalization after the index hospitalization through month 12 that met one of the following criteria: 1.) at least a 24-hour stay (or a change in calendar date if the time of admission/discharge is not available) or 2.) reported as an in-patient admission by the patient/proxy with an admission date (complete or month and year) and no discharge date (i.e., length of stay could not be derived). Unit of measurement is the total number of re-hospitalizations for each subject (e.g., if a subject had 3 re-hospitalizations, then the outcome is 3 for the subject). |
| Secondary | All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | 30 days | All-cause mortality or all-cause hospitalization over 30 days |
| Secondary | Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call | Baseline, 1 month, 6 months, 12 months | QOL as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (range, 0-100 with 100 indicating best health status). The KCCQ was administered prior to randomization (collected by the site) and at Months 1, 6 and 12 (ascertained at the Call Center visits). The outcome is the least square means in Torsemide and Furosemide groups where the difference = Torsemide mean minus Furosemide mean at the monthly assessment. |
| Secondary | Symptoms of Depression as Measured by the Patient Health Questionnaire-2 (PHQ-2) | Month 1, month 6, month 12 | Depression was assessed by the Patient Health Questionnaire-2 (PHQ-2) over 12 months. The PHQ-2 inquires about the frequency of depressed mood and anhedonia (inability to feel pleasure) over the past two weeks. The responses to the questions are scored 0 = Not at all, 1 = Several days, 2 = More than half the days, and 3 = Nearly every day. The PHQ-2 total score is obtained by adding the score for each question. The PHQ-2 total score ranges from 0-6. Reported as the number of patients with a total score \<3 versus \>=3. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-cause Mortality, as Measured by Follow-up Phone Call or NDI | up to 30 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | up to 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Re-hospitalizations, as Measured by Follow-up Phone Call | up to 12 months | Participants who had at least one re-hospitalization. | re-hospitalizations | NUMBER |
| SECONDARY | All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call | Baseline, 1 month, 6 months, 12 months | Participants with both baseline and monthly KCCQ-CSS scores available (i.e., change from baseline at the month assessment could be analyzed). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Symptoms of Depression as Measured by the Patient Health Questionnaire-2 (PHQ-2) | Month 1, month 6, month 12 | Participants with data available at each time point. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-cause Mortality, as Measured by Follow-up Phone Call or NDI | Torsemide | 373 | Participants | ||
| All-cause Mortality, as Measured by Follow-up Phone Call or NDI | Furosemide | 374 | Participants | ||
| All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Torsemide | 677 | Participants | ||
| All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Furosemide | 704 | Participants | ||
| Total Re-hospitalizations, as Measured by Follow-up Phone Call | Torsemide | 940 | re-hospitalizations | ||
| Total Re-hospitalizations, as Measured by Follow-up Phone Call | Furosemide | 987 | re-hospitalizations | ||
| All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Torsemide | 149 | Participants | ||
| All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Furosemide | 157 | Participants | ||
| Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call | Torsemide | Baseline to Month 1 | 69.52 | 95% Confidence Interval 67.53 to 71.51 | score on a scale |
| Change in Health-related Quality of Life (QOL), as Measured by Follow-up Phone Call | Furosemide | Baseline to Month 1 | 68.22 | 95% Confidence Interval 66.22 to 70.23 | score on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Torsemide | 1,431 | |
| Overall Study | STARTED | Furosemide | 1,428 | |
| Overall Study | COMPLETED | Torsemide | 1,378 | |
| Overall Study | COMPLETED | Furosemide | 1,368 | |
| Overall Study | NOT COMPLETED | Torsemide | 53 | |
| Overall Study | NOT COMPLETED | Furosemide | 60 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Torsemide | 373 | 1,431 |
| Total, all-cause mortality | Furosemide | 374 | 1,428 |
| Total, other adverse events | Torsemide | 0 | 0 |
| Total, other adverse events | Furosemide | 0 | 0 |
| Total, serious adverse events | Torsemide | 0 | 0 |
| Total, serious adverse events | Furosemide | 0 | 0 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL125511 | TRANSFORM-HF CCC | VELAZQUEZ, ERIC J; MENTZ, ROBERT JOHN | YALE UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2021 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Torsemide vs Furosemide: All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Trial comparisons |
| Torsemide vs Furosemide: All-cause Mortality, as Measured by Follow-up Phone Call or NDI | Trial comparisons |
| Torsemide vs Furosemide: All-cause Mortality or All-cause Hospitalization, as Measured by Follow-up Phone Call or NDI (for Death) | Trial comparisons |
| Torsemide vs Furosemide: deaths from any cause | 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/NCT03296813
GET https://conductscience.org/api/trials/v1/NCT03296813/results?page=2