Bioimpedance-Guided Diuretics and Cardiac Progression in Asymptomatic Heart Failure

NCT07801144 | Completed

• 1 other identifier: 2018/476
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Heart Failure

Keywords

hypervolemia; renal failure,; Diuretic treatment; heart failure

Outcome Measures

Primary Outcomes (1)

• Change in Fluid Volume Status

  Evaluation of the change in patient's fluid status (hydration/overhydration) measured via bioimpedance analysis (BIA) parameters.

  Baseline and 12 months

Secondary Outcomes (1)

• Change in Left Ventricular Ejection Fraction

  Baseline and 12 months

Study Arms (2)

Negative Hydration Group

Positive Hydration Group

Positive Hydration Group

Positive Hydration Group

Eligibility Criteria

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

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri Training and Research Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kocasinan, Kayseri, 38020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure; Edema; Renal Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Specialist

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 3, 2026
• Study Start: May 20, 2019
• Primary Completion: August 20, 2020
• Study Completion: November 20, 2020
• Last Updated: September 3, 2026

Record last verified: 2026-09

Locations

TU (1)