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Study of dapagliflozin effects in patients hospitalized with acute heart failure

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What is this study about?

This study focuses on patients with acute heart failure, a condition where the heart cannot pump blood effectively, leading to symptoms like shortness of breath, fatigue, and fluid buildup in the body. The study will test a medication called dapagliflozin, given as a film-coated tablet, compared to a placebo. The purpose is to determine if starting this medication during hospital stay can improve outcomes for patients who have been stabilized after being admitted for acute heart failure.

The medication or placebo will be taken by mouth once daily for two months. Cardiovascular health and heart failure symptoms will be monitored throughout the study period. This includes tracking any heart-related deaths or worsening of heart failure symptoms that might require additional treatment or hospital readmission.

The study will involve patients who have different levels of heart function, as measured by left ventricular ejection fraction (the amount of blood pumped out by the heart’s main chamber). Both patients with and without type 2 diabetes can participate in the study. The medication will only be started after patients have shown initial improvement with standard hospital treatment for their heart failure.

1 Initial medication phase

You will receive either dapagliflozin (10 mg film-coated tablet) or a placebo tablet once daily

This phase starts while you are still in the hospital, between 24 hours and 14 days after your admission

Before starting the medication, your condition must be stable for at least 12 hours without requiring increased doses of intravenous medications

You must not have received intravenous heart medications for at least 24 hours before starting the study medication

2 Treatment duration

The medication (either dapagliflozin or placebo) will be taken by mouth once daily for 2 months

You will need to take one tablet each day at approximately the same time

3 Monitoring period

Your heart health will be monitored throughout the study period

The medical team will track any changes in your heart condition

They will check for signs of heart failure getting worse

Your kidney function will be regularly assessed through blood tests

4 Follow-up assessment

The study will monitor specific health events, including:

Any hospital readmissions due to heart problems

Urgent medical visits requiring intravenous medications

Changes in kidney function

Blood pressure changes that might require medical attention

Who Can Join the Study?

  • Must be currently hospitalized for acute heart failure with symptoms such as:
    – Worsening breathing difficulties or shortness of breath at rest
    – Increasing tiredness
    – Rapid weight gain
    – Worsening swelling in body
  • Must show signs of excess fluid in the body, such as:
    – Swollen neck veins
    – Crackling sounds in lungs
    – Fluid in abdomen
    – Swelling in legs and ankles
    – Signs of fluid in lungs on chest X-ray
  • Must be receiving increased heart failure treatment during hospital stay, including:
    – Higher doses of water pills (diuretics)
    – Receiving medications through an IV
    – New medications to help heart function
  • Must have had a heart function test (ejection fraction measurement) within the past 12 months
  • Must have elevated levels of certain heart failure markers (NT-proBNP or BNP) in blood tests during current hospital stay
  • Must be stable for at least:
    – 12 hours without needing increased IV water pills
    – 24 hours without needing IV medications for heart function
  • Can participate whether or not you have type 2 diabetes
  • Both men and women can participate
  • Must be an adult (18 years or older)

Who Cannot Join the Study?

  • Age below 18 years old
  • Known allergy or sensitivity to dapagliflozin (the study medication)
  • Currently pregnant or breastfeeding women
  • Type 1 diabetes (a condition where the body does not produce insulin)
  • Recent heart attack (within the last 30 days)
  • Severe kidney disease (severely reduced kidney function)
  • Current participation in other clinical trials
  • Systolic blood pressure (upper number) below 95 mmHg
  • Life-threatening conditions other than heart failure
  • History of serious allergic reactions to medications
  • Unable to provide informed consent
  • Severe liver disease (severely reduced liver function)
  • History of frequent urinary tract infections (infections in the bladder or urinary system)
  • Plans for major surgery during the study period
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Lodz Poland
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie Rzeszow Poland
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia

Other Sites

Site Name City Country Status
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Gottsegen National Cardiovascular Center Budapest Hungary
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
University Of Debrecen Debrecen Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnow Poland
Nemocnice Slany Slany Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Siedlcach Siedlce Poland
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Krajska zdravotni a.s. Teplice Czechia
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Krajska nemocnice Liberec a.s. Liberec Czechia
Oblastni nemocnice Kolin a.s. nemocnice Stredoceskeho kraje Kolin Czechia
Mazowiecki Szpital Bródnowski Śródmiejskie Centrum Kliniczne Warsaw Poland
Iqthvewpa Fym Curnotjd Ath Eftgwuhcdvaq Mdkdeztm Prague Czechia
Kiklfyfdvipa Ofkxwcvn Éqlvlhqjjzx Caxuogwgqfnhc – Hrubyhwtawvt Budapest Hungary
Skyrrne Saqw Kluczbork Poland
Uoiciqtnmrnoyg Cdpaoar Mkyjvyzb Mrbwhfyw I Tywsfkogenw Gdynia Poland
Wsoqqraopd Sjhuyrj ikx Zkwmx z Zkepvxtyyl Tkjufafrfil w Thopibvfney Tarnobrzeg Poland
Clcdzjo Zrrmocc Tylqes Svb z oipr Tuchow Poland
Ssirmtrvlev Pypjuwjom Zsjxuu Zizuedbm Osucxs Zumgdjzmak W Pfwrdrvnah Przasnysz Poland
Bdmcpiconsi Vgbntpmkw Ogzjxtvxfqwy Kecskemet Hungary
Fjrlruwn nbsmoullt Mhznu a Hmcfpzw Prague Czechia
Gydchjjirfgbpebcu Vikgumlfp Pppm Aufcvd Elrjecxt Oyaqor Kxfpmq Gyor Hungary
Uwopbsxzyyzena Cpqhhyt Ksfvfrfjy Gdansk Poland
Micilxi Svwbert Zydqmsvif w Opwdjwkmc Olsztyn Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
08.03.2023
Hungary Hungary
Not recruiting
08.03.2023
Poland Poland
Not recruiting
08.03.2023

Trial locations

Investigated drugs:

Dapagliflozin is a medication used to treat heart failure. It belongs to a class of drugs called SGLT2 inhibitors that help improve heart function. The medication is started while patients are still in the hospital after being treated for acute heart failure. It works by helping the body remove excess sugar and fluid through urination, which can help reduce the workload on the heart and improve symptoms of heart failure.

Acute Heart Failure – A sudden onset condition where the heart cannot pump enough blood to meet the body’s needs. This condition develops rapidly, causing fluid to build up in the lungs and other body tissues. The main signs include severe shortness of breath, rapid or irregular heartbeat, and fatigue. Acute heart failure can occur in people who have never had heart problems before, or it can be a sudden worsening of existing chronic heart failure. The condition often requires immediate medical attention as symptoms typically appear or worsen quickly. Fluid retention can cause swelling in the legs and ankles, and patients may experience difficulty breathing, especially when lying down.

Trial ID:
2024-517612-29-00
Protocol code:
D1690C00078
Trial Phase:
Human Pharmacology (Phase I) – Other

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