Trial · NCT07008365
The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
NCT07008365, Phase 3, Recruiting, Instituto de Investigación Sanitaria Aragón
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure. Trials, record NCT07008365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07008365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure
- NCT number
- NCT07008365
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 168 participants, estimated
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Conditions
- Acute Heart Failure, Congestive Heart Failure, Intraabdominal Hypertension, Cardio-Renal Syndrome
- Interventions
- Furosemide 20 Milligrams
- First posted
- 2025-06-06
- Last updated
- 2025-06-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Significant reduction in congestion (ADVOR scale) | After the first 72 hours of endovenous loop diuretic treatment | To evaluate the significant reduction in congestion (ADVOR Scale) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound). ADVOR Scale: Oedema: No oedema (0 points), Trace oedema (1 point), Clear pitting oedema (2 points), Visual deformation above ankle (3 points), Visual deformation above knee (4 points). Pleural effusion: No pleural effusion (0 points), Minor (2 points), Major (3 points) Ascites: No ascites (0 points), Minor ascites (2 points), Significant ascites (3 points) TOTAL SCORE: Oedema score + Pleural effusion + Ascitis. Minimum 0 points; Maximum 10 points |
| Secondary | Significant pulmonary congestion reduction through lung ultrasound assessment (b-lines) | From time to randomization until the first 72 hours of endovenous loop diuretics treatment at the Internal Medicine ward | To evaluate the complete resolution of pulmonary congestion as assessed by ultrasound (B-lines) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). The degree of pulmonary tissue congestion will be quantified using clinical ultrasound. Eight quadrants (four left and four right) will be examined. A quadrant will be considered positive for pulmonary tissue congestion if three or more B-lines are detected. Minimum: 0 quadrants; Maximum 8 quadrants |
| Secondary | Significant intravascular congestion reduction through venous excess ultrasound score (VEXUS score) | After the first 72 hours of endovenous loop diuretic treatment | To evaluate the significant reduction in intravascular congestion (inferior vena cava diameter and venous excess ultrasound protocol) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard of care treatment group with the interventional group (intra-abdominal pressure and ultrasound). VEXUS score * Grade 0: No congestion; inferior vena cava vein (IVC) diameter \< 2 cms * Grade 1: Mild congestion, IVC 2\> cms + any combination of normal or mildly abnormal waveforms of doppler veins explored. * Grade 2: Moderate congestion, IVC \> 2 cms + at least one severely abnormal pattern of doppler veins explored. * Grade 3: Severe congestion, IVC \> 2cms + two or more severely abnormal waveforms of doppler veins explored. Minimum 0 points; Maximum 3 points |
| Secondary | Total diuresis response | After the first 72 hours of endovenous loop diuretic treatment | To evaluate the diuretic response (total urine volume/total dose of furosemide administered) after the first 72 hours of intravenous diuretic treatment in the hospital ward, comparing the standard treatment group with the intervention group (intra-abdominal pressure and ultrasound). |
| Secondary | Total dose of diuretic treatment | After the first 72 hours of endovenous loop diuretic treatment | To compare the days and doses of intravenous loop diuretics and hydrochlorothiazide used during the first 72 hours of hospitalization between the standard treatment group and the intervention group. |
| Secondary | Number of patients treated for worsening heart failure | From date of discharge until 30-days post-hospitalization visit. From date of discharge until 90-days post-hospitalization visit. (cut-off period 1-year) | Differences in heart failure worsening (defined as the need for intravenous loop diuretic treatment after hospital discharge, whether in a day hospital, emergency department, or due to new hospital admissions at 30 and 90 days) between the two groups. |
| Secondary | Total number of patients with cardiovascular death | From date of discharge until the date of cardiovascular death (cut-off period 1 year) | Differences in cardiovascular death incidence |
| Secondary | guided directed medical therapy (GDMT) | From date of admission up to discharge, from date of discharge up to 30 days after and from date of discharge up to 90 days (cut-off period 1-year) | Prevalence of GDMT prescribed at discharge according to left ventricular ejection fraction and actual heart failure guidelines |
| Secondary | length of stay | From date of randomization until date of discharge (cut-off period 4 weeks) | Differences in length of stay between both arms |
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/NCT07008365
GET https://conductscience.org/api/trials/v1/NCT07008365/registered