Study groups
The research physician about this research
The study compound may potentially be used for the treatment of worsening heart failure. With heart failure, the heart cannot pump the blood well enough anymore. This results in blood and fluid collecting in the lungs and legs. Worsening heart failure is usually treated with water pills. These are medicines that help the body eliminate excess fluid through urination. However, these water pills do not fully resolve the symptoms. This leaves the patients at risk of suffering new episodes of worsening heart failure and subsequent hospitalization.
The clinical trial consists of three parts: cohort A, cohort B and cohort C. You can only participate in one cohort.
The study compound has been given to humans before. The most common side effect was redness of the skin around the injection site. This was likely caused by widening of blood vessels in the skin and went away on its own after a few days. The purpose of this clinical trial is to find ways to reduce redness of the skin at the injection site (cohort A). We will also investigate whether the injection site on the body makes a difference (cohort B). In cohort C, we further examine the methods of administration from cohort A and cohort B. We will look at how these methods have an effect on how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body.
In cohort A, you will be given the study compound as an injection under the skin in the abdomen four times in total. Once, only the compound is administered. Another time, the drug is given followed by a cold pack applied to the injection site for 15 minutes. Twice, a (different) cream or gel that can reduce pain and inflammation is applied to the injection site.
In cohortB, you will be given the study compound as an injection under the skin in the abdomen, upper arm and thigh. The order of the injection location will be random. You will receive the study compound once daily for three days.
In cohort C, you will be given the study compound as an injection under the skin in either the abdomen, upper arm or thigh. You will receive the study compound once during each of the two periods (so twice in total). One of the methods to reduce injection site reactions will also be used: a cold pack for 15 minutes, or one of two different creams or gels that can reduce pain and inflammation.
The compound has already been tested in healthy individuals. In these clinical trials, the following side-effects were observed most often: redness of the skin at the injection site and headache. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
Who can participate?
Note:
What is the compensation for this research?
You will receive a gross compensation of € 1.987,- for participation in cohort A.
For participation in cohort B of the trial, you will receive a gross compensation of € 1.759,-.
You will receive a gross compensation of € 4.273,- for participation incohort C.
Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.
How long does this research take?
Cohort A of the trial consists of 1 period during which you will stay in the research facility in Groningen for 5 days (4 nights) followed by 2 short visits. The follow-up visit will take place between 26 and 28 days after your departure from the research facility.
Cohort B of the trial consists of 1 period during which you will stay in the research facility in Groningen for 4 days (3 nights), followed by 2 short visits. The follow-up visit will take place between 26 and 28 days after your departure from the research facility.
Cohort C of the trial consists of 2 periods during which you will stay in the research facility in Groningen for 4 days (3 nights) per period, followed by 4 short visits per period. The follow-up visit will take place between 21 and 23 days after your last short visit.
Note: You must be available for all dates to be able to participate in this clinical trial.
If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.