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Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance

NCT05986773 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-14

No results posted yet for this study

Summary

The P-VALUE-AHF trial is a multicenter, randomized, open-label, parallel-group trial on the diuretic and decongestive effects of different diuretic escalation strategies in patients with acute heart failure and diuretic resistance.

The main aims are

* to compare the diuretic efficacy of three therapeutic strategies in patients with acute heart failure and diuretic resistance.
* to assess the improvement in clinical congestion and to compare the symptom-relief among the different treatment regimens

Conditions

  • Acute Heart Failure
  • Diuretic Resistance

Interventions

DRUG

Furosemide

Two to five hours after the initial standard dose Furosemide i.v, the patients are randomized towards 3 study-specific diuretic regimens: the first group will receive a doubled dose Furosemide i.v. (group FF), the second group will receive a combination of standard dose Furosemide i.v. and Metolazone 5 mg p.o. (group FM), the third group will receive a combination of standard dose Furosemide i.v. and Acetazolamide 500 mg i.v. (group FA).

DRUG

Metolazone

Two to five hours after the initial standard dose Furosemide i.v, the patients are randomized towards 3 study-specific diuretic regimens: the first group will receive a doubled dose Furosemide i.v. (group FF), the second group will receive a combination of standard dose Furosemide i.v. and Metolazone 5 mg p.o. (group FM), the third group will receive a combination of standard dose Furosemide i.v. and Acetazolamide 500 mg i.v. (group FA).

DRUG

Acetazolamide

Two to five hours after the initial standard dose Furosemide i.v, the patients are randomized towards 3 study-specific diuretic regimens: the first group will receive a doubled dose Furosemide i.v. (group FF), the second group will receive a combination of standard dose Furosemide i.v. and Metolazone 5 mg p.o. (group FM), the third group will receive a combination of standard dose Furosemide i.v. and Acetazolamide 500 mg i.v. (group FA).

Sponsors & Collaborators

  • Ospedale Regionale di Lugano

    collaborator OTHER

  • Stadtspital Zürich

    lead OTHER

Principal Investigators

  • Mattia Arrigo, PD, Dr. med. · City Hospital Zürich Triemli, Birmensdorferstr. 497, 8063 Zürich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05986773 on ClinicalTrials.gov