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NCT Number: NCT07781826

Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Institute of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland

Wroclaw, 50-556, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic heart failure

Exclusion criteria

  • GFR <25 ml/min/1,73 m2

Treatment and study plan

Neurohormonal blockade intensification

Drug

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.

Primary outcomes

  1. Change in pre-diuretic sodium avidity

    Time frame: After two weeks of MRA intensification treatment

    Change in pre-diuretic sodium avidity, defined as the change in pre-diuretic spot urinary sodium concentration (uNa⁺) in response to MRA intensification.

  2. Change in post-diuretic sodium avidity

    Time frame: After 2 weeks of MRA intensification treatment

    Change in post-diuretic sodium avidity, defined as the change in post-diuretic uNa⁺ in response to MRA intensification.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Acronym: uGDMT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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