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Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients

Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07781826
Acronym
uGDMT
Enrollment
80
Registered
2026-08-24
Start date
2024-03-01
Completion date
2025-12-31
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

chronic heart failure, finerenone, eplerenone, sodium avidity, natriuresis, diuresis

Brief summary

Heart failure is a condition that can affect a person's health and daily life. In this study, we aim to investigate how diuretic medications work and how they affect patients with heart failure. Our main objective is to understand how the body responds to these medications and whether treatment can be adjusted to make it more effective and safer for patients. Fluid and electrolyte imbalances are an important aspect of heart diseases. In heart failure, the body may retain excessive amounts of sodium and water, leading to symptoms of the condition. Excessive sodium retention is associated with disease severity and hormonal disturbances. One of the best ways to assess this phenomenon is to measure the amount of sodium in the urine. Although medications for heart failure are available, we do not fully understand how they affect sodium excretion. A better understanding of this mechanism may help improve and individualize treatment. Our objectives are: * To determine the levels of sodium and other urinary components before the administration of diuretic medication. * To assess the body's response to diuretic medication in terms of sodium excretion. * To investigate whether the body's response to diuretic medication affects the dose of medication required by the patient. * To examine how the response to diuretic medication changes over time. * To determine whether treatment intensification affects sodium retention and the volume and composition of urine following the administration of diuretic medication. Three study visits are planned. During each visit, the first morning urine sample will be analyzed before the administration of diuretic medication. Another sample will be obtained after the medication is administered, followed by a three-hour urine collection. Blood samples will also be collected for laboratory testing. The second visit will take place 7-14 days after the first visit, and the patient's treatment will be intensified. The third visit will take place 14 days after the second visit and will follow a procedure similar to that of the first visit.

Detailed description

During the second visit, neurohormonal blockade was intensified by either initiating or up-titrating treatment with eplerenone or finerenone, according to the assigned study group.

Interventions

DRUGNeurohormonal blockade intensification

During the second visit, neurohormonal blockade was intensified by either initiating or up-titrating treatment with eplerenone or finerenone, according to the assigned study group.

Sponsors

Wroclaw Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Chronic heart failure

Exclusion criteria

* GFR \<25 ml/min/1,73 m2

Design outcomes

Primary

MeasureTime frameDescription
Change in post-diuretic sodium avidityAfter 2 weeks of MRA intensification treatmentChange in post-diuretic sodium avidity, defined as the change in post-diuretic uNa⁺ in response to MRA intensification.
Change in pre-diuretic sodium avidityAfter two weeks of MRA intensification treatmentChange in pre-diuretic sodium avidity, defined as the change in pre-diuretic spot urinary sodium concentration (uNa⁺) in response to MRA intensification.

Countries

Poland

Contacts

STUDY_CHAIRJan Biegus, MD, PhD

Wroclaw Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026