TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years;

• HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology \[5\];

• Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF;

• An elevated NT-proBNP \>300pg/ml;

• Requiring the need for iv diuretics.

Locations
Other Locations
Netherlands
Amphia ziekenhuis
RECRUITING
Breda
Zuyderland MC
RECRUITING
Heerlen
Contact Information
Primary
Sandra van Wijk, MD, PhD
s.vanwijk@zuyderland.nl
088 - 459 9701
Backup
Mick Hoen, MD
m.hoen@zuyderland.nl
088 - 459 9701
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2026-08-27
Participants
Target number of participants: 466
Treatments
Experimental: Tailored, Urine sodium guided, intensified diuretic strategy
Active_comparator: Usual care
Related Therapeutic Areas
Sponsors
Leads: Zuyderland Medisch Centrum

This content was sourced from clinicaltrials.gov