Not yet recruitingNAINTERVENTIONAL

Training in HFpEF-PH

This study is investigating if a special exercise program can help people who have both heart failure with preserved ejection fraction (HFpEF) and high blood pressure in their lungs (pulmonary hypertension, or PH). We know exercise helps people with heart failure, but we need more information about those who also have PH. The main goals are to find out if the exercise program is safe and well-tolerated, if it improves how well people can exercise, their quality of life, and how their heart and blood vessels work. Participants will either do the special exercise program or continue with standard care. This research aims to understand how best to support this specific group of patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Heidelberg University

Enrolment target

Start

01 Feb 2023

Estimated completion

01 Dec 2026

Pulmonary Hypertension Due to Left Heart Disease Heart Failure With Preserved Ejection Fraction

What is this study about?

This study is looking into a special exercise program for people who have two conditions: heart failure with preserved ejection fraction (HFpEF) and high blood pressure in the lungs, also known as pulmonary hypertension (PH). Let's break that down a little.

HfpEF means your heart muscle still pumps blood out strongly, but it has trouble relaxing and filling with blood properly. This can lead to a build-up of pressure, and sometimes, this pressure can spread to the blood vessels in your lungs, causing pulmonary hypertension. When you have both HFpEF and PH, it can make symptoms like breathlessness and tiredness worse. We know that exercise is generally good for people with heart failure because it can help them feel better and reduce hospital visits. However, we're not sure if the usual exercise programs are safe and helpful for people who also have this specific type of high blood pressure in their lungs.

That's where this study comes in. We want to see if a carefully designed exercise program can safely improve how well people with both conditions can exercise, how they feel day-to-day (their quality of life), and help their heart and blood vessels work better. This study will compare the special exercise program to standard care to understand if it makes a positive difference for this particular group of patients, for whom there isn't much specific research yet. The aim is to find better ways to support people living with these conditions.

Key takeaways

This study is for people with specific heart and lung conditions: HFpEF and pulmonary hypertension.
It's testing a special exercise program to see if it helps improve health and well-being.
Participation involves either an exercise program or standard care, and various health assessments.
The goal is to find better ways to support patients with both HFpEF and pulmonary hypertension.
You can withdraw from the study at any time without affecting your medical treatment.

Who may be eligible?

This study is looking for both male and female volunteers aged 18 years and older. To be considered, you must have been diagnosed with both heart failure with preserved ejection fraction (HFpEF) and high blood pressure in your lungs (pulmonary hypertension), which would have been confirmed through a special heart test called a right heart catheterisation. Your heart's pumping action (ejection fraction) must also be at least 50%.

It's important that your medical treatment, including diuretics (water tablets), is stable and hasn't changed for at least a month before starting the study. Any medical treatment you are currently on, apart from diuretics, should remain the same throughout the study. You also need to be able to understand what the study involves and be willing to sign a consent form.

There are several reasons why you might not be able to join. These include certain types of pulmonary hypertension, severe problems with your heart valves, pregnancy or breastfeeding, or if you have difficulty walking. If you have severe lung disease, certain active heart problems like unstable angina, severe liver issues, very low haemoglobin, or very low blood pressure, you would also not be eligible. Finally, if you are already taking part in another medical study or have a history of not being able to fully cooperate with medical instructions, you would not be able to participate.

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.

Are you 18 years old or older?
Have you been diagnosed with both HFpEF and pulmonary hypertension (PH)?
Has your medical treatment, especially for your heart, been stable for at least one month?
Are you able to understand and sign a consent form?
Do you have severe heart valve problems or severe lung disease?
Are you currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either be assigned to a special exercise program or continue with your usual medical care. The study aims to look at your exercise ability, quality of life, and how your heart and blood vessels are working. This will likely involve a combination of assessments, which might include specific exercise tests to measure your fitness, questionnaires about your daily life and how you're feeling, and possibly some blood tests. There might also be heart scans or other measurements to check your heart's function.

You will have regular appointments for these assessments throughout the study period. The total duration of your participation will be explained in detail by the study team, and it's important to understand the number of visits and the time commitment involved. You will receive clear instructions about any medication, and it's crucial not to change your regular medications (other than diuretics) during the study without discussing it with the study team. More specific details about the exercise program, if you are in that group, will also be given.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as improved exercise capacity and quality of life if the specialised exercise program proves effective. You would also be contributing valuable information that could help others with similar conditions in the future. However, as with any exercise program, there are potential risks, such as muscle soreness, fatigue, or, rarely, more serious heart-related events during exercise, which the study team will monitor closely. There are also risks associated with certain tests, though these are typically small. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital
Verified postcode
Heidelberg, Germany
Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
Verified postcode
Vilnius, Lithuania

Common questions

What is HFpEF?

HFpEF stands for Heart Failure with preserved Ejection Fraction. It means your heart muscle pumps blood out well, but it has trouble relaxing and filling with blood properly.

What is pulmonary hypertension (PH)?

Pulmonary hypertension is high blood pressure in the arteries that go from your heart to your lungs. It can make you feel breathless and tired.

Will I have to exercise if I join?

If you are in the exercise group, yes, you will follow a special exercise program. If you are in the standard care group, you will continue with your usual activities.

How long will the study last?

The information provided here doesn't state the exact duration, but the study team will explain the full timetable and how many visits are needed.

Can I stop participating if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Ekkehard Grünig, MD

ekkehard.gruenig@med.uni-heidelberg.de +496221396 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.