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Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients

NCT07781826 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Neurohormonal 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 & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Jan Biegus, MD, PhD · Wroclaw Medical University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

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 NCT07781826 on ClinicalTrials.gov