Trial · NCT04163588
Sequential Nephron Blockade in Acute Heart Failure
NCT04163588, Phase 3, Unknown, Policlinico Casilino ASL RMB
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequential Nephron Blockade in Acute Heart Failure. Trials, record NCT04163588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04163588
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequential Nephron Blockade in Acute Heart Failure
- NCT number
- NCT04163588
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 310 participants, estimated
- Lead sponsor
- Policlinico Casilino ASL RMB
- Conditions
- Acute Heart Failure
- Interventions
- Metolazone, Loop Diuretics
- First posted
- 2019-11-15
- Last updated
- 2019-11-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | change in the serum creatinine level and the change in weight, considered both as a bivariate response and with their single components | 72 hours | The bivariate response will be displayed on a two-dimensional grid with individual data points for each patient representing paired changes in both creatinine (inmg/dL) and weight (in kilograms) 76 hours after randomization. A confidence region for the average difference between treatment arms in this bivariate response can be described as an ellipse, and the 2 treatment arms will be compared statistically with the use of the Hotelling T- square, which is a multivariate analog of the 2-sample t test used with a single continuous variable (Ann Math Stat. 1931; 2:360-78). Evaluating these 2 important responses to treatment as a bivariate end point reflects clinically important responses to therapy and avoids the requirement of making adjustments in sample size to prevent a type 1 error that would be necessary if the end points were considered separately (Eur J Heart Fail. 2003; 5:717-23). |
| Secondary | global well-being assessment by a visual-analogue scale | 72 hours | Global well-being is assessed with the use of a visual-analogue scale that ranged from 0 to 100, with higher scores indicating greater well-being (Chest 1999;116:1208-17) |
| Secondary | body weight assessment | 72 hours | total changes in body weight in kilograms |
| Secondary | congestion | 72 hours | proportion of patients who were free from congestion (defined as jugular venous pressure of \<8 cm, with no orthopnoea and with trace peripheral oedema or no oedema) |
| Secondary | treatment failure | 7 days | death, worsening/persistent HF, need for dialysis, crossover from standard pharmacologic care to sequential nephron blockade or the occurrence of a serious adverse event during the first 7 days from admission |
| Secondary | Biomarkers | 72 hours, 7 days or discharge | changes in NT-proBNP levels (in pg/mL) at 72 hours, day 7 or discharge |
| Secondary | clinical end-point | 60 days | composite of death, rehospitalization, or an emergency room visit within 60 days |
| Secondary | hospitalization-death | 60 days | composite of total number of days hospitalized or dead during the 60 days after randomization |
| Secondary | Total net fluid loss | 76 hours | total urinary output (in milliliters) from randomization to 76 hours |
| Secondary | dyspnea assessment by a visual-analogue scale | 76 hours | Dyspnea is assessed with the use of a visual-analogue scale that ranged from 0 to 100, with higher scores indicating less dyspnea (Chest 1999;116:1208-17) |
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.
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 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/NCT04163588
GET https://conductscience.org/api/trials/v1/NCT04163588/registered