Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients

NCT07781826 | Completed Early Phase 1

• 3 other identifiers: 229/2024SUBK.A460.25.041IDUB.A46B.24.002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in pre-diuretic sodium avidity

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

  After two weeks of MRA intensification treatment

• Change in post-diuretic sodium avidity

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

  After 2 weeks of MRA intensification treatment

Study Arms (2)

Eplerenone

ACTIVE COMPARATOR

25mg 1x/day

Drug: Neurohormonal blockade intensification

Finerenone

EXPERIMENTAL

The dose is determined based on the patient's GFR - either 10mg or 20mg

Drug: Neurohormonal blockade intensification

Interventions

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.

Eplerenone; Finerenone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure

You may not qualify if:

• GFR \<25 ml/min/1,73 m2

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

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

Wroclaw, 50-556, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Biegus, MD, PhD

  Wroclaw Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)