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A feasibility study of dapagliflozin for elderly patients hospitalized with chronic heart failure.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Chronic Heart Failure, a long-term condition where the heart does not pump blood as well as it should. The research specifically looks at cases of Decompensated Chronic Heart Failure, which occurs when the heart condition suddenly worsens, often requiring emergency medical attention. The goal of this study is to assess the feasibility of starting a specific type of medication early during a hospital visit.

The treatment being investigated is dapagliflozin propanediol monohydrate, which belongs to a class of drugs known as gliflozins. Participants in the study may receive this medication via oral use, meaning it is taken by mouth. Some participants will receive this early treatment along with telephone counseling, while others will receive standard care provided by the hospital. The study will monitor how well the treatment is accepted and followed over a period of time.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry and medication administration

    Upon entering the study, dapagliflozin propanediol monohydrate is administered via oral use (taking the medicine by mouth).

    The dosage is 10 mg (milligrams) to be taken as part of the treatment process.

  2. Step 2

    Initial assessments

    Clinical signs such as dyspnea (shortness of breath), asthenia (weakness or lack of energy), and congestive signs (signs of fluid buildup) are monitored.

    Blood tests are performed to measure nt-probnp (a marker used to check the status of heart failure) and to evaluate renal function (how well the kidneys are working, specifically the glomerular filtration rate, which measures how much blood passes through the kidneys).

  3. Step 3

    Seven-day follow-up

    At 7 days, or earlier if hospital discharge (leaving the hospital) occurs sooner, clinical signs and blood markers like nt-probnp and renal function are reassessed.

  4. Step 4

    Three-month follow-up

    At 3 months, a final evaluation is conducted to monitor mortality (death from any cause), rehospitalization (returning to the hospital), or unplanned visits related to chronic heart failure.

    The quality of life is assessed using a specific questionnaire to check for any significant changes since leaving the hospital.

    The levels of nt-probnp, clinical signs, and renal function are measured again to observe long-term progress.

Who can join the trial?

9 criteria

  • Both men and women can participate if they are 75 years of age or older.
  • Participants must be admitted to the emergency department (the hospital area for urgent medical care) due to acute decompensated heart failure, which is a sudden worsening of a long-term heart condition where the heart cannot pump blood effectively.
  • The patient must show worsening symptoms, such as dyspnea (shortness of breath), asthenia (extreme tiredness or lack of strength), sudden weight gain, or edema (swelling caused by fluid buildup in the body).
  • Medical staff must find physical signs of fluid buildup, such as jugular venous distension (visible bulging of the veins in the neck), crackles (rattling sounds in the lungs when listening with a stethoscope), ascites (fluid buildup in the belly), hepatomegaly (an enlarged liver), or peripheral edema (swelling in the legs or arms).
  • Blood tests must show high levels of natriuretic peptides, which are substances produced by the heart that increase when the heart is under stress. Specifically, BNP or NT-proBNP levels must meet certain high numerical thresholds depending on whether the patient has a regular heart rhythm or atrial fibrillation (an irregular and often rapid heart rhythm).
  • Patients must require an increase in their medication, such as taking higher doses of diuretics (medicines that help the body get rid of extra water and salt through urine) or starting treatment through an IV.
  • The patient must be someone who is being considered for hospitalization (staying in the hospital for treatment).
  • The patient must not already be taking gliflozins, which is a specific type of medication (such as empagliflozin or dapagliflozin) used to treat certain conditions.
  • The patient must provide a signed and dated informed consent, which is a written document showing they understand the study and agree to participate.

Who cannot join the trial?

15 criteria

  • Having Type 1 diabetes, which is a condition where the body does not produce insulin.
  • Being unable to give consent (permission to join), follow directions, or complete the required follow-up visits.
  • Having any other medical condition that could be dangerous for you or might change the study results.
  • Not being part of or receiving benefits from the French social security system.
  • Being in a waiting period for another study or being listed in the national volunteer registry.
  • Being transferred to the Cardiology Department (the part of the hospital that specializes in heart care).
  • Being sent home or to a residential care facility (a home for elderly people who need extra help with daily tasks).
  • Having chronic kidney disease with a glomerular filtration rate (a measure of how well the kidneys filter waste) of less than 25 ml/min.
  • Experiencing cardiogenic shock, which is a life-threatening condition where the heart suddenly cannot pump enough blood to the body.
  • Having acute coronary syndrome (a sudden reduction in blood flow to the heart) shown on an ECG (a test that records the heart's electrical activity) or experienced within the last 30 days.
  • Having severe valvular heart disease (problems with the heart's valves that control blood flow) that might need surgery during the study.
  • Having a percutaneous or surgical coronary intervention (a procedure to open blocked heart arteries) planned or completed within the last 30 days.
  • Having a known intolerance or hypersensitivity (an allergic reaction) to the medicine or any of its inactive ingredients.
  • Being a person deprived of liberty (such as being in prison).
  • Being under legal protection measures, receiving psychiatric care, or being admitted to a health or social care facility.
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Investigated drugs

Dapagliflozin is a medication taken by mouth that helps the body get rid of extra sugar through urine, which can help improve how the heart functions in people with heart failure.

What is already known about the treatment

Dapagliflozin propanediol monohydrate - This medication is taken by mouth as a pill to help manage certain health conditions. It is currently used in medical practice to treat type 2 diabetes and to help protect the heart and kidneys. This drug belongs to a group of medicines called SGLT2 inhibitors, which work by preventing the kidneys from absorbing too much sugar back into the blood, allowing the extra sugar to be removed through urine. By lowering blood sugar and reducing fluid buildup, it helps ease the workload on the heart.

Investigated diseases

Chronic decompensated heart failure - This condition occurs when the heart is no longer able to pump enough blood to meet the body's needs, leading to a sudden worsening of symptoms. It typically follows a long-term period of the heart muscle weakening over time. As the condition progresses, fluid can build up in the lungs, legs, and abdomen. This buildup often causes increased shortness of breath, fatigue, and swelling. The disease involves a cycle of stability followed by periods of acute distress that require medical attention.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-521101-40-00Protocol code2024/882Estimated enrolment144 patientsSponsorCentre Hospitalier Regional Universitaire

sourced from the EU Clinical Trials Register and site verification

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