Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients (uGDMT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Wroclaw, Poland, 50-556
- Institute of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic heart failure
Exclusion Criteria:
- GFR <25 ml/min/1,73 m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Eplerenone
25mg 1x/day
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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.
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Experimental: Finerenone
The dose is determined based on the patient's GFR - either 10mg or 20mg
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in pre-diuretic sodium avidity
Time Frame: After two weeks of MRA intensification treatment
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Change in pre-diuretic sodium avidity, defined as the change in pre-diuretic spot urinary sodium concentration (uNa⁺) in response to MRA intensification.
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After two weeks of MRA intensification treatment
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Change in post-diuretic sodium avidity
Time Frame: After 2 weeks of MRA intensification treatment
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Change in post-diuretic sodium avidity, defined as the change in post-diuretic uNa⁺ in response to MRA intensification.
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After 2 weeks of MRA intensification treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jan Biegus, MD, PhD, Wroclaw Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 229/2024
- SUBK.A460.25.041 (Other Grant/Funding Number: Wroclaw Medical University, Poland)
- IDUB.A46B.24.002 (Other Grant/Funding Number: Wroclaw Medical University, Poland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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