Study on Using Furosemide and Hydrochlorothiazide for Treating Patients with Acute Heart Failure

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What is this study about?

This clinical trial focuses on studying the treatment of Acute Heart Failure, a condition where the heart suddenly becomes unable to pump blood effectively. The study will use medications called Furosemide and Hydrochlorothiazide, which are diuretics. Diuretics help the body get rid of excess fluid by increasing urine production. Furosemide will be administered either as a solution for injection or in tablet form, while Hydrochlorothiazide will be given as a tablet.

The purpose of the study is to evaluate how well these treatments can resolve congestion, which is the buildup of fluid in the body, within the first 72 hours of treatment. Congestion is a common problem in patients with heart failure and can lead to symptoms like swelling and difficulty breathing. The study will compare the standard treatment approach with an intervention that uses measurements of intra-abdominal pressure and ultrasound to guide the treatment. Intra-abdominal pressure refers to the pressure within the abdomen, and ultrasound is a technique that uses sound waves to create images of the inside of the body.

Participants in the study will receive either the standard treatment or the intervention treatment. The study will monitor the effectiveness of the treatments in reducing congestion over a period of time. The goal is to determine which approach is more effective in helping patients with acute heart failure recover more quickly and comfortably. The study is expected to continue until 2026.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of heart failure, and specific blood test results.

Informed consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted, which includes measuring intra-abdominal pressure and performing a clinical ultrasound.

These assessments help guide the diuretic treatment plan.

3 intravenous diuretic treatment

The treatment begins with the administration of furosemide intravenously. This medication helps reduce fluid buildup in the body.

The goal is to achieve complete resolution of congestion within the first 72 hours of treatment.

4 oral medication administration

In addition to intravenous treatment, furosemide and hydrochlorothiazide are administered orally.

These medications are taken to maintain the reduction of fluid buildup.

5 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to evaluate the effectiveness of the diuretic therapy.

The absence of congestion is assessed using the ADVOR scale after 72 hours.

6 completion of the trial

The trial concludes with a final evaluation to determine the success of the treatment in resolving congestion.

The study is estimated to end by September 30, 2026.

Who Can Join the Study?

Men or women over 18 years of age
Diagnosis of HF (Heart Failure) based on the latest guidelines published in 2022
NT-proBNP greater than 1000 pg/mL or BNP greater than 250 pg/mL. These are blood tests that help diagnose heart failure.
Bladder catheterization to measure intra-abdominal pressure. This involves placing a tube in the bladder to check pressure inside the abdomen.
Presence of congestion in the blood vessels or mixed areas, shown by signs like swelling (edema), fluid in the abdomen (ascites), or fluid around the lungs (pleural effusion)
Signature of the informed consent, which means agreeing to participate after understanding the study details

Who Cannot Join the Study?

Patients who do not have Acute Heart Failure cannot participate. Acute Heart Failure is a condition where the heart suddenly can’t pump enough blood to meet the body’s needs.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are considered part of a vulnerable population, such as those who might not be able to give informed consent, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hannfggs Sil Akvvowd dy Avarmx	Avilés (Asturias)	Spain
Hkwfqogj Rwjbb Surix	Tudela	Spain
Hnrezmde Uswnqbibfmwsr dq A Cwlyfa	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Diuretics are medications used to help the body get rid of excess fluid by increasing urine production. In this trial, they are used to treat patients with acute heart failure by reducing fluid buildup in the body, which can help alleviate symptoms such as swelling and difficulty breathing. The trial aims to evaluate how effective diuretics are in resolving congestion within the first 72 hours of treatment.

Acute Heart Failure – This condition occurs when the heart suddenly becomes unable to pump blood effectively, leading to a rapid onset of symptoms. It often results in fluid buildup in the lungs and other parts of the body, causing shortness of breath, swelling, and fatigue. The heart’s reduced ability to circulate blood can lead to congestion, which is a key feature of this disease. Acute heart failure can develop quickly, often within hours or days, and requires immediate medical attention. It may be triggered by factors such as heart attacks, high blood pressure, or other underlying heart conditions. The progression involves worsening symptoms if not managed promptly, emphasizing the need for timely intervention.

Trial ID:

2024-512901-22-00

Protocol code:

PI23/00797

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Using Furosemide and Hydrochlorothiazide for Treating Patients with Acute Heart Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?