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Ongoing Clinical Trials for Hypervolaemia

Hypervolaemia, a condition characterized by excess fluid in the body, is the focus of 4 ongoing clinical trials. These studies are testing various medications and treatment approaches to help manage fluid overload and related cardiovascular complications in different patient populations, particularly those in intensive care units and those at risk of heart failure.

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Study on Baxdrostat and Dapagliflozin for Preventing Heart Failure in Patients at High Risk

This trial is examining whether adding Baxdrostat to Dapagliflozin can help prevent heart failure in people who are at high risk. The study focuses on patients aged 40 and older who have Type 2 Diabetes and established cardiovascular disease, along with high blood pressure.

Inclusion criteria: Participants must have been diagnosed with Type 2 Diabetes requiring treatment, have a history of cardiovascular conditions such as heart disease or peripheral arterial disease, and have high blood pressure with specific readings at screening. They must also have controlled potassium levels based on their kidney function and at least one additional risk factor for heart failure, such as being 70 years or older, having reduced kidney function, or having a history of irregular heartbeats.

Exclusion criteria: Patients who have recently experienced a heart attack or stroke, those with severe kidney or liver disease, people allergic to the study medications, and pregnant or breastfeeding women cannot participate. Those already in another clinical trial or unable to follow study procedures are also excluded.

Study focus: The trial aims to determine whether the combination of Baxdrostat and Dapagliflozin is more effective than Dapagliflozin alone in reducing heart failure events and cardiovascular death. Participants will be monitored for up to 38 weeks to assess outcomes including hospitalizations and heart-related deaths.

Investigational drugs: Baxdrostat is being studied for its potential to reduce heart failure risk when combined with Dapagliflozin. Dapagliflozin is already used to manage heart conditions and diabetes by helping the body remove excess sugar through urine, which also benefits heart health.

Study on Fluid Removal Using Furosemide and Amiloride Hydrochloride in ICU Patients with Fluid Overload

This study is testing whether Furosemide, a medication that helps remove excess fluid, can improve recovery in critically ill intensive care unit patients experiencing fluid overload compared to allowing the body to remove fluid naturally.

Inclusion criteria: Patients must be 18 years or older, admitted to the ICU for an urgent or emergency reason, and considered clinically stable with adequate blood pressure and controlled lactate levels. They must have fluid accumulation estimated to be at least 5% of their ideal body weight, determined by daily fluid balance, weight changes, and clinical examination.

Exclusion criteria: Patients without fluid overload, those not in the ICU, individuals younger than 18, and those belonging to vulnerable populations requiring special protection are excluded from the study.

Study focus: The trial compares Furosemide with a placebo to see if active fluid removal helps patients spend more days alive and out of the hospital within 90 days. Researchers will also monitor survival rates, days without life support, serious side effects, and long-term quality of life and cognitive function up to one year.

Investigational drugs: Furosemide is administered intravenously to promote fluid removal from the body. It works by inhibiting fluid reabsorption in the kidneys, leading to increased urine production and helping to reduce swelling and symptoms associated with fluid retention.

Study on Sodium Zirconium Cyclosilicate for Improving Heart Failure Treatment in Patients with High-Risk Hyperkalemia

This trial is investigating whether Sodium Zirconium Cyclosilicate can help patients with heart failure maintain better doses of their heart medications by controlling potassium levels in the blood, a common problem called hyperkalemia.

Inclusion criteria: Participants must be over 18 years old with a left ventricular ejection fraction of 40% or less, confirmed by recent heart ultrasound. They should have stable heart failure symptoms classified as NYHA class II to IV and be on optimal heart failure treatment. Their treatment with mineralocorticoid receptor antagonists should be less than ideal, and they must meet specific potassium level criteria based on their medical history and current kidney function.

Exclusion criteria: Patients with high-risk hyperkalemia, those with heart failure not receiving optimal treatment, and those with suboptimal heart failure management are excluded from participation.

Study focus: The study evaluates whether Sodium Zirconium Cyclosilicate can safely help patients maintain stable doses of heart failure medications without experiencing high potassium levels. Researchers will assess quality of life and medication tolerance throughout the trial.

Investigational drugs: Sodium Zirconium Cyclosilicate works by controlling blood potassium levels, allowing safer use of aldosterone receptor antagonists. These heart failure medications block aldosterone, a hormone that causes salt and water retention, thereby reducing strain on the heart and improving symptoms.

Study on the Effects of CDR132L in Patients with Reduced Heart Function After a Heart Attack

This trial is studying a new treatment called CDR132L in patients whose hearts do not pump blood effectively after experiencing a heart attack, a condition known as reduced left ventricular ejection fraction.

Inclusion criteria: Patients must be between 30 and 80 years old and have experienced a spontaneous heart attack within the past 14 days. Their left ventricular ejection fraction must be 45% or less as measured after the heart attack. Participants must weigh 120 kg or less, have NT-proBNP levels between 125 and 8000 pg/ml, and have undergone a procedure to open blocked heart arteries. Those with a history of previous heart attacks can still participate.

Exclusion criteria: Patients with recent heart attacks or acute left-sided heart failure, those with reduced heart function not receiving standard care, and individuals from vulnerable populations are excluded.

Study focus: The trial evaluates the safety and effectiveness of CDR132L in improving heart function after a heart attack. Participants receive either a low dose, higher dose, or placebo through intravenous infusion, with three doses given 28 days apart. Researchers monitor changes in heart function and overall health through imaging tests and blood work.

Investigational drugs: CDR132L is an experimental medication delivered directly into the bloodstream through IV infusion. It is designed to improve the heart’s pumping ability by targeting specific molecules that affect heart function, potentially serving as a helpful addition to standard treatments for weakened hearts following a heart attack.

Summary

The four ongoing clinical trials for hypervolaemia represent diverse approaches to managing fluid overload and related cardiovascular complications. The studies are concentrated primarily in European countries, with particularly strong representation in Czechia, Netherlands, Sweden, Germany, and Denmark. The trials span different patient populations, from critically ill ICU patients to those at risk of heart failure and patients recovering from heart attacks.

The treatments being tested include both established medications like Furosemide and Dapagliflozin, as well as experimental drugs such as Baxdrostat, Sodium Zirconium Cyclosilicate, and CDR132L. A notable focus across several trials is the management of fluid balance and electrolyte levels, particularly potassium, in patients with cardiovascular conditions. This reflects the complex relationship between fluid overload, heart function, and metabolic balance in managing these conditions.

The trials demonstrate a shift toward combination therapies and precision medicine approaches, with studies examining how new medications can optimize existing treatments or address complications that limit current therapeutic options. The geographical distribution suggests strong clinical research infrastructure in Central and Northern Europe for cardiovascular and critical care studies.

Ongoing Clinical Trials on Hypervolaemia

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