The role of intra-abdominal pressure and point of care ultrasound to guide decongestive therapy in Heart Failure (ABDOPOCUS-HF)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Instituto De Investigacion Sanitaria Aragon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

10 Feb 2025 → ongoing

Decision date (initial)

2024-08-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Diagnosis

To evaluate the complete resolution of congestion (ADVOR scale) after the first 72 hours of intravenous diuretic treatment on the hospital ward, between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound)

Secondary objectives 11

1. To evaluate the complete resolution of pulmonary congestion by ultrasound (lines B) after the first 72 hours of intravenous diuretic treatment on the hospital ward, between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound).
2. To evaluate the significant reduction in intravascular congestion (inferior vena cava diameter and VExUS protocol), after the first 72 hours of intravenous diuretic treatment on the hospital ward, between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound).
3. To evaluate the diuretic response (total diuresis volume/total dose of furosemide administered) after the first 72 hours of intravenous diuretic treatment on the hospital ward, between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound).
4. To compare the days and doses of intravenous loop diuretic and hydrochlorothiazide used during the first 72 hours of hospital admission between the standard treatment group and the intervention group.
5. Differences in the worsening of HF (defined as the need to receive treatment with intravenous loop diuretics after hospital discharge, either in the day hospital, in the emergency room or due to new hospital admissions at 30 and 90 days) between the two groups.
6. To compare the incidence of death of cardiovascular origin at 30 and 90 days post-hospitalization.
7. To analyze whether the intervention group strategy, compared to the standard strategy, significantly reduces the mean hospital stay (days of admission).
8. To analyze the proportion of patients prescribed GDMT (4 drugs in ICFEP and glucosurics in the rest) at discharge and at 30-90 days.
9. To analyze whether the strategy of the intervention group is associated with a lower percentage of development of deterioration in renal function (defined as an increase greater than or equal to 0.3 mg/dL of creatinine at any time during hospital admission).
10. To analyze whether the strategy of the intervention group is associated with a lower percentage of the appearance of ionic alterations related to the use of intravenous diuretics (hyponatremia < 135 mmol/L, hypokalemia < 3.5 mmol/L or hyperkalemia > 5 .1 mmol/L).
11. To evaluate the change in weight between admission and after the first 72 hours of intravenous diuretic treatment in the inpatient ward between the standard treatment group and the intervention group (intra-abdominal pressure and ultrasound)

Conditions and MedDRA coding

Acute Heart Failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Men or women over 18 years of age
2. Diagnosis of HF based on the latest HF guidelines published in 2022
3. NT-proBNP > 1000 pg/mL or BNP > 250 pg/mL
4. Bladder catheterization in order to perform intra-abdominal pressure measurement
5. Intravascular or mixed pattern of congestion, defined as the presence of one or more clinical signs of congestion (edema, ascites and/or pleural effusion)
6. Signature of the informed consent

Exclusion criteria 16

1. Patient with stay in the internal medicine department > 24 hours
2. Serum hemoglobin < 9 g/dL
3. Pregnancy or lactation
4. Previous history of hypersensitivity to hydrochlorothiazide or furosemide.
5. Patients with recent cardiac surgery (last year) or cardiac transplant recipients
6. Need for inotropic support to maintain adequate cardiac and/or renal output
7. Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization)
8. Patient refusal to participate in the clinical trial
9. Inability or contraindication to bladder catheterization
10. Systolic blood pressure at admission < 100 mmHg
11. Heart rate at admission > 170 beats per minute (bpm)
12. Cardiogenic shock
13. Acute myocardial ischemia
14. Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).
15. Patients whose origin is the Intensive Care Unit
16. Renal transplant recipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Congestion absence after the first 72h of intravenous diuretic treatment in hospitalization as determined by the ADVOR scale.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Instituto De Investigacion Sanitaria Aragon

Sponsor organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Address

Edificio Ciba, Avenida De San Juan Bosco 13 Avenida De San Juan Bosco 13

City

Zaragoza

Postcode

50009

Country

Spain

Scientific contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Contact name

Clinical Investigation Unit

Public contact point

Organisation

Fundacion Instituto De Investigacion Sanitaria Aragon

Contact name

Clinical Investigation Unit

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications