Heart FailureNCT07801144
Bioimpedance-Guided Diuretics and Cardiac Progression in Asymptomatic Heart Failure
An observational study of Heart Failure, run by Kayseri Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). This prospective study aims to assess the effects of diuretic treatment in systolic HF patients who have no clinical signs of congestion but have hypervolemia as measured by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2019to 20 Nov 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: The study population consists of adult patients (aged 18 years and older) with a confirmed diagnosis of heart failure and a reduced left ventricular ejection fraction (LVEF < 40%), who are routinely followed up or newly diagnosed at the internal medicine and cardiology outpatient clinics of Kayseri City Training and Research Hospital. Specifically, the cohort targets patients who do not exhibit obvious clinical signs of volume overload on standard physical examination (such as edema, hepatomegaly, or ascites) but are identified as hypervolemic based on objective bioimpedance analysis (overhydration value > 0).
Who may be able to join
- Patients aged 18 years and older (regardless of gender)
- Confirmed diagnosis of heart failure (newly diagnosed or previously under follow-up in the internal medicine or cardiology outpatient clinic)
- Left ventricular ejection fraction (LVEF) < 40% as determined by echocardiography
- Patients who do not have hypervolemia detected on physical examination
- Fluid volume status (overhydration [OH]) value greater than zero, as measured by bioimpedance analysis, thereby classifying them as hypervolemic for the study
- Willingness to participate and ability to provide written informed consent prior to any study-related procedures
Who cannot join
- Patients under 18 years of age
- Pregnant women
- Patients with clinically evident decompensated heart failure requiring intravenous diuretic therapy
- Presence of edema, hepatomegaly, or ascites upon physical examination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital
Kocasinan, Kayseri, 38020
About this study
Official title: Effect of Diuretic Treatment Based on Bioimpedance Analysis Measurements on Cardiac Progression in Patients With Asymptomatic Heart Failure: 1-Year Period, Longitudinal Study
It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). This prospective study aims to assess the effects of diuretic treatment in systolic HF patients who have no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). The study compares the outcomes of patients receiving bioimpedance-guided diuretic therapy to maintain negative hydration versus those followed without diuretic therapy over a 1-year period.
Read the detailed description
Background and Objectives It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). The primary objective of this prospective study is to assess the effects of diuretic treatment in patients with systolic HF who exhibit no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). Furthermore, the study aims to compare the clinical outcomes of these patients with a control group not receiving diuretic treatment.
Methods
This prospective study includes adult patients with systolic HF. The patients are assigned into two groups:
Negative Hydration Group: Patients receive diuretic therapy and are maintained in a state of negative hydration according to BIA measurements.
Positive Hydration Group: Patients are followed without diuretic therapy.
All patients are followed for a total duration of 1 year, with clinical evaluations and BIA measurements repeated at 4-month intervals.
- Conditions
- Heart Failure
- Keywords
- hypervolemia, renal failure,, Diuretic treatment, heart failure
- Medical subject headings
- Heart Failure, Edema, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Negative Hydration Group | Positive Hydration Group | |
| Positive Hydration Group | Positive Hydration Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fluid Volume Status
Evaluation of the change in patient's fluid status (hydration/overhydration) measured via bioimpedance analysis (BIA) parameters.
Measured: Baseline and 12 months
Secondary outcomes (1)
Change in Left Ventricular Ejection Fraction
Assessment of cardiac progression by measuring the change in left ventricular ejection fraction percentage using transthoracic echocardiography.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start20 May 2019
- Primary completion20 Aug 2020
- Study completion20 Nov 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kayseri Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berkan AKÇAKAYA, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801144
- Sponsor's protocol ID
- 2018/476
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diuretic Treatment Based on Bioimpedance Analysis Measurements on Cardiac Progression in Patients With Asymptomatic Heart Failure: 1-Year Period, Longitudinal Study
- ClinicalTrials.gov ID
- NCT07801144
- Acronym / sponsor ID
- 2018/476
- Conditions
- Heart Failure
- Keywords
- hypervolemia, renal failure,, Diuretic treatment, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kayseri Training and Research HospitalOther government
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 3 Sep 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.
It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). This prospective study aims to assess the effects of diuretic treatment in systolic HF patients who have no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). The study compares the outcomes of patients receiving bioimpedance-guided diuretic therapy to maintain negative hydration versus those followed without diuretic therapy over a 1-year period.
Detailed description
Background and Objectives It has not been clearly elucidated whether volume control with diuretics is essential at an early stage in patients with heart failure (HF). The primary objective of this prospective study is to assess the effects of diuretic treatment in patients with systolic HF who exhibit no clinical signs of congestion but have hypervolemia as measured by bioimpedance analysis (BIA). Furthermore, the study aims to compare the clinical outcomes of these patients with a control group not receiving diuretic treatment.
Methods
This prospective study includes adult patients with systolic HF. The patients are assigned into two groups:
Negative Hydration Group: Patients receive diuretic therapy and are maintained in a state of negative hydration according to BIA measurements.
Positive Hydration Group: Patients are followed without diuretic therapy.
All patients are followed for a total duration of 1 year, with clinical evaluations and BIA measurements repeated at 4-month intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Hydration Group | – | –Positive Hydration Group |
| Positive Hydration Group | – | –Positive Hydration Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) with a confirmed diagnosis of heart failure and a reduced left ventricular ejection fraction (LVEF < 40%), who are routinely followed up or newly diagnosed at the internal medicine and cardiology outpatient clinics of Kayseri City Training and Research Hospital. Specifically, the cohort targets patients who do not exhibit obvious clinical signs of volume overload on standard physical examination (such as edema, hepatomegaly, or ascites) but are identified as hypervolemic based on objective bioimpedance analysis (overhydration value > 0).
Key inclusion criteria (6 listed)
- Patients aged 18 years and older (regardless of gender)
- Confirmed diagnosis of heart failure (newly diagnosed or previously under follow-up in the internal medicine or cardiology outpatient clinic)
- Left ventricular ejection fraction (LVEF) < 40% as determined by echocardiography
- Patients who do not have hypervolemia detected on physical examination
- Fluid volume status (overhydration [OH]) value greater than zero, as measured by bioimpedance analysis, thereby classifying them as hypervolemic for the study
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Pregnant women
- Patients with clinically evident decompensated heart failure requiring intravenous diuretic therapy
- Presence of edema, hepatomegaly, or ascites upon physical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Fluid Volume Status
Time frame: Baseline and 12 months
Evaluation of the change in patient's fluid status (hydration/overhydration) measured via bioimpedance analysis (BIA) parameters.
1 secondary outcome
Change in Left Ventricular Ejection Fraction
Time frame: Baseline and 12 months
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 3 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Kayseri Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 3 Sep 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 Turkey (Türkiye). 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.
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 Fluid Volume Status (time frame: Baseline and 12 months). 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 3 Sep 2026.