Heart FailureEarly Phase 1uGDMTNCT07781826
Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients
A Early Phase 1 study testing Neurohormonal blockade intensification in people with Heart Failure, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Neurohormonal blockade intensification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure
Who cannot join
- GFR <25 ml/min/1,73 m2
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Heart Diseases, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, Poland
Wroclaw, 50-556
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Neurohormonal blockade intensification
- Keywords
- chronic heart failure, finerenone, eplerenone, sodium avidity, natriuresis, diuresis
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurohormonal blockade intensificationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone | Active comparator | 25mg 1x/day Receives: Drug: Neurohormonal blockade intensification |
| Finerenone | Experimental | The dose is determined based on the patient's GFR - either 10mg or 20mg Receives: Drug: Neurohormonal blockade intensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 2 weeks of MRA intensification treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Biegus, MD, PhD, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781826
- Sponsor's protocol ID
- 229/2024
- Other IDs
- SUBK.A460.25.041, IDUB.A46B.24.002
- Acronym
- uGDMT
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained from participants does not include the transfer of individual-level data to external researchers. Study findings will be published exclusively in an aggregated and anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Neurohormonal Blockade on Natriuresis in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT07781826
- Acronym / sponsor ID
- uGDMT / 229/2024
- Conditions
- Heart Failure
- Keywords
- chronic heart failure, finerenone, eplerenone, sodium avidity, natriuresis, diuresis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone | Active comparator | Drug: Neurohormonal blockade intensification25mg 1x/day |
| Finerenone | Experimental | Drug: Neurohormonal blockade intensificationThe dose is determined based on the patient's GFR - either 10mg or 20mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic heart failure
Key exclusion criteria (1 listed)
- GFR <25 ml/min/1,73 m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurohormonal blockade intensificationDuring the second visit, neurohormonal blockade was intensified by either initiating or up-titrating treatment with eplerenone or finerenone, according to the assigned study group. | Drug | Eplerenone, Finerenone |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained from participants does not include the transfer of individual-level data to external researchers. Study findings will be published exclusively in an aggregated and anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Biegus, MD, PhD study chair
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neurohormonal blockade intensification in people with Heart Failure, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pre-diuretic sodium avidity (time frame: After two weeks of MRA intensification treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.