Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

(14308) Randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the hemodynamic effects of Riociguat (BAY 63-2521) as well as safety and kinetics in patients with pulmonary hypertension associated with left ventricular systolic dysfunction.

This research is investigating a new medicine called Riociguat for people who have high blood pressure in their lungs because their left heart chamber isn't pumping blood effectively (a condition called pulmonary hypertension associated with left ventricular systolic dysfunction). The study is designed to see how Riociguat affects the pressure in the lung arteries and if it improves other heart measurements. Participants will receive either the study drug or a placebo (a dummy pill with no active medicine), and neither they nor their doctors will know which one they are getting. This helps ensure the results are fair. The study will also carefully check for any side effects and how the body handles the medicine. It's an early-stage study, meaning it's exploring whether the treatment works and is safe enough to study further.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bayer AG

Enrolment target

Start

25 Mar 2024

Patients symptomatic with pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD)

What is this study about?

This research is looking into a medicine called Riociguat for people who have a condition where there's high blood pressure in the arteries of their lungs, specifically because the main pumping chamber of their heart (the left ventricle) isn't working as well as it should. This condition can make everyday activities difficult and affect your quality of life.

The main goal of this study is to see if Riociguat can help lower this high blood pressure in the lungs. Researchers will measure the pressure in the lung arteries at the beginning of the study and again after 16 weeks to see if there's a change. They will also be very carefully watching for any side effects the medicine might cause and how the body uses and gets rid of the drug, which is important for understanding its safety and effectiveness.

Beyond just checking blood pressure, the study will also look at how Riociguat might affect other important aspects of your health. This includes how well your heart is pumping, how far you can walk in six minutes, your overall quality of life, and certain markers in your blood that can indicate heart health. This detailed approach helps researchers get a full picture of the medicine's potential benefits and risks. Studies like this are crucial because they help doctors understand if new treatments can really make a difference for patients living with challenging heart and lung conditions.

Key takeaways

This study is for adults with high blood pressure in the lungs caused by a weak heart.
It's testing a new medicine called Riociguat against a dummy pill (placebo).
Neither you nor your doctor will know if you're getting the active drug or placebo.
The main goal is to see if Riociguat lowers lung blood pressure and improves heart function.
Participation involves regular visits, tests, and taking the assigned study medication.
You can stop participating in the study at any time if you wish.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years or older, regardless of your gender. You must have been diagnosed with pulmonary hypertension because your left heart chamber isn't pumping blood effectively. The research team will do several checks to make sure you fit all the necessary health requirements for the study.

There might be certain health conditions or medications that would prevent you from taking part, even if you have the primary condition the study is looking at. For example, if you have other serious health problems or are taking medicines that could interfere with the study drug, you might not be able to join. All these details are checked carefully by the study doctors.

It's important to remember that meeting the basic age and condition criteria doesn't automatically mean you can participate. The study team will need to review your full medical history and conduct examinations to confirm your eligibility and ensure your safety throughout the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Have I been told I have high blood pressure in my lungs because my left heart chamber is weak?
Am I able to visit the study clinic regularly?
Am I comfortable taking a study medication, knowing I might get a dummy pill?
Do I have any other major health conditions or take medicines that might affect my participation?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular visits to the study clinic over a period of time. You will be given either the study medicine, Riociguat, or a dummy pill (placebo) to take regularly, as neither you nor your study doctor will know which one you are receiving. During your visits, you will have various health checks, which may include things like blood tests, heart scans (echocardiograms), and tests to measure the pressure in your heart and lungs, potentially using a thin tube inserted into a blood vessel (called a right heart catheter). You will also complete questionnaires about your quality of life and possibly a six-minute walking test to see how far you can walk. The total duration of your participation in the study is 16 weeks, with follow-up appointments after that.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit if Riociguat proves effective in lowering your lung blood pressure and improving your heart function, although there's no guarantee the treatment will work for you. On the other hand, Riociguat could cause side effects, which the study team will monitor closely. You might also receive the placebo, meaning you wouldn’t get any active medication, but you would still receive close medical attention. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy
—
Unverified
Czechia
—
Unverified
Germany

Common questions

What is pulmonary hypertension with left ventricular systolic dysfunction?

This means you have high blood pressure in the arteries of your lungs because the main pumping chamber of your heart (your left ventricle) isn't squeezing blood out as strongly as it should.

What is Riociguat?

Riociguat is the name of the medicine being tested in this study. It's being investigated to see if it can help improve blood pressure in the lungs.

What does 'double-blind' mean?

Double-blind means that neither you, the patient, nor your study doctor will know if you are receiving the active medicine or a dummy pill (placebo). This helps make the study results as fair and unbiased as possible.

What is a Phase II study?

A Phase II study is an early stage of clinical research. It focuses on exploring whether a new treatment works and is safe enough to be studied further in larger groups of people.

Will I have to stay in hospital?

The study involves regular clinic visits and tests, but it doesn't specify that you would have to stay in hospital, although some tests like a right heart catheterisation are usually done in a hospital setting and might involve a short stay.