Trial · NCT03505788
Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
NCT03505788, Phase 4, Completed, Ziekenhuis Oost-Limburg; results first posted 2024-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR). Trials, record NCT03505788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03505788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acetazolamide in Decompensated Heart Failure With Volume OveRload (ADVOR)
- NCT number
- NCT03505788
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 519 participants, actual
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Conditions
- Acute Decompensated Heart Failure, Volume Overload
- Interventions
- Acetazolamide, Placebo
- First posted
- 2018-04-23
- Last updated
- 2024-10-28
- Results first posted
- 2024-10-28
- Limitations and caveats
1. Nearly all patients were white~2. Patients had a history of chronic heart failure and had been receiving long-term outpatient treatment with at least 40 mg of furosemide equivalent.~3. Patients in the two trial groups received similar loop diuretics.~4. The congestion score focused on the presence of edema in the lower limb, pleural effusion, and ascites - reflective of mainly extracellular volume overload~5. The trial design excluded use of SGLT2 inhibitors
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful Decongestion | 4 days | defined as the absence of signs of volume overload, within 3 days after randomization and with no indication for escalation of decongestive therapy. |
| Secondary | Mortality | 3 months | All-cause mortality during the first 3 months after start of the study |
| Secondary | Hospital Readmission | 3 months | If a patient is readmitted to the hospital within 3 months, this data will be collected |
| Secondary | Length of Index Hospital Admission | 3 months | The time frame between hospital admission and discharge will be calculated |
| Secondary | EuroQoL Five Dimensions Questionnaire (EQ-5D) | at baseline, day 4 (or discharge), at 3 months | A questionnaire about the patients' quality of life will be performed at baseline, the morning of day 4, at any readmission, 3 months. The questionnaire is divided into 5 levels of severity with a score varying from 1 to 5. 1 indicates no problems and 5 indicates severe problems. The EQ-5D-5L health status, defined by the EQ-5D-5L descriptive system, are converted into a single index value (utility data). Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Successful Decongestion | 4 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Readmission | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Length of Index Hospital Admission | 3 months | days | GEOMETRIC_MEAN | |
| SECONDARY | EuroQoL Five Dimensions Questionnaire (EQ-5D) | at baseline, day 4 (or discharge), at 3 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Successful Decongestion | Placebo | 79 | Participants | ||
| Successful Decongestion | Acetazolamide | 108 | Participants | ||
| Mortality | Placebo | 31 | Participants | ||
| Mortality | Acetazolamide | 39 | Participants | ||
| Hospital Readmission | Placebo | 45 | Participants | ||
| Hospital Readmission | Acetazolamide | 47 | Participants | ||
| Length of Index Hospital Admission | Placebo | 9.9 | 95% Confidence Interval 9.1 to 10.8 | days | |
| Length of Index Hospital Admission | Acetazolamide | 8.8 | 95% Confidence Interval 8.0 to 9.5 | days | |
| EuroQoL Five Dimensions Questionnaire (EQ-5D) | Placebo | Baseline | 0.571 | Standard Deviation 0.027 | score on a scale |
| EuroQoL Five Dimensions Questionnaire (EQ-5D) | Acetazolamide | Baseline | 0.546 | Standard Deviation 0.027 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 260 | |
| Overall Study | STARTED | Acetazolamide | 259 | |
| Overall Study | COMPLETED | Placebo | 257 | |
| Overall Study | COMPLETED | Acetazolamide | 254 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Acetazolamide | 5 |
Source ClinicalTrials.gov
Adverse events46
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 | Cardiac arrhythmia | Cardiac disorders | Placebo | 30 | 259 | |
| other | Cardiac arrhythmia | Cardiac disorders | Acetazolamide | 29 | 256 | |
| other | Decreased and nonspecific blood pressure disorders and shock | Cardiac disorders | Placebo | 14 | 259 | |
| other | Decreased and nonspecific blood pressure disorders and shock | Cardiac disorders | Acetazolamide | 20 | 256 | |
| other | Heart failure | Cardiac disorders | Placebo | 83 | 259 | |
| other | Heart failure | Cardiac disorders | Acetazolamide | 69 | 256 | |
| other | Hyperkaelemia | General disorders | Placebo | 19 | 259 | |
| other | Hyperkaelemia | General disorders | Acetazolamide | 14 | 256 | |
| other | Hypokaelemia | General disorders | Placebo | 38 | 259 | |
| other | Hypokaelemia | General disorders | Acetazolamide | 60 | 256 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 31 | 259 |
| Total, all-cause mortality | Acetazolamide | 39 | 256 |
| Total, other adverse events | Placebo | 184 | 259 |
| Total, other adverse events | Acetazolamide | 192 | 256 |
| Total, serious adverse events | Placebo | 124 | 259 |
| Total, serious adverse events | Acetazolamide | 123 | 256 |
Source ClinicalTrials.gov
Papers5
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acetazolamide vs Placebo: Successful Decongestion | Trial comparisons |
| Acetazolamide vs Placebo: Mortality | Trial comparisons |
| Acetazolamide vs Placebo: deaths from any cause | Trial comparisons |
| Acetazolamide vs Placebo: Hospital Readmission | Trial comparisons |
| Acetazolamide vs Placebo: 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/NCT03505788
GET https://conductscience.org/api/trials/v1/NCT03505788/events?page=2