PRA-172081 Heart failure tot € 2.209,-

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Description

Study of a new compound that is being developed for the treatment of heart failure

Requested participants

  • M/F, Healthy, 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 6 -19 days stay

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Research details

Particulars

  • You are a non-smoker
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and heigth in meters.
  • For females, you are allowed to participate in this study if you are using sufficient contraception (i.e. a cupper intrauterine device and a condom; hormonal contraceptives are not allowed) or if you have been postmenopausal for a minimum of 12 months (12 months without periods) or if you have been sterilized at least 6 months ago.
  • To determine if you are eligible for participation in this study, you will undergo a medical screening.
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Compensation

You will receive the following gross compensation for participation in one of the groups of this study: 

Group A-1, A-2, and A-4 to A-6 € 827,-

Group A-3 € 1.729,-

Group A-7 € 2.314,-

Group A-PD1a to A-PD1h € 1.127,-

Group B-1 and B-2 € 2.209,-

Travelling expenses will be reimbursed based on the distance traveled (€ 0,19 net per kilometer) with a minimum of € 12,- and a maximum of € 160,- (840 kilometers) per return, regardless of the mode of transportation.

Period of stay and research

For Group A-1, A-2, A-4 to A-6 and A-PD1a to A-PD1h the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 6 days (5 nights).

For Group A-3 the study consists of 2 periods during which you will stay in our research facility in Groningen (location UMCG) for 6 days (5 nights) per period.

For Group A-7 the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 20 days (19 nights). 

For Group B-1 and B-2 the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 19 days (18 nights).

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Information sheet PRA-172081

Type of study

The purpose of this study is to investigate how safe the new compound is when it is administered to healthy volunteers. It will also be investigated how quickly and to what extent it is absorbed and eliminated from the body and the effect of the new compound on the body will be investigated. The effects of the new compound will be compared to the effects of placebo (a medicine without any active ingredient). The new compound is not registered as a drug and has not been given to humans before.

The study will only take place after it has been approved by the Independent Ethics Committee.

Risks and medical supervision

The new compound may eventually be used for the treatment of heart failure. Heart failure is characterized by the inability of the heart to deliver a sufficient supply of blood and oxygen to the organs in the body. Signs and symptoms may include shortness of breath, tiredness, a limited ability to exercise, and leg swelling. The new compound is able to bind a protein that is expressed in the human heart. Binding of the new compound to the protein exerts a series of signaling events that may result in enhancement of contractility of cardiac cells and mild dilatation of the blood vessels. In heart failure patients, evidence suggests that short-term intravenous infusion of a compound similar to the new compound results in improvement of cardiac output.

The new compound may cause side effects, but since it will be administered to humans for the first time in this study, side effects in humans have not been reported to date. The new compound has been studied in animals and there were no findings related to that.

Based on the mechanism of action, side effects may occur that are observed with a similar compound that has been infused in approximately 58 people at doses that are similar (or higher) than those to be used in this study. No significant bad reactions were reported. The similar compound causes blood vessels to open which results in lower blood pressure and faster heart rate. Low blood pressure may cause dizziness, fainting, sweating, nervousness, nausea and chest or abdominal pain. Increased heart rate may cause a sensation of pounding in the chest which may cause feelings of anxiety or nervousness.

You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening

Conditions for participation

You are a healthy male or female between 18 and 55 years old. You may only take part in the study if you do not smoke. Women must use acceptable methods of contraception (hormonal contraceptives are not allowed or they must be sterilized or they must be post-menopausal. The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study are not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine are allowed. Before you are allowed to take part in this study, you will be medically screened; this screening will take place within 4 weeks before the start of the study.

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Group A-3

€ 1.729,-

13 days stay

  • 2 Nov 2017 up to and including 14 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable

Group A-5

€ 827,-

6 days stay

  • 16 Nov 2017 up to and including 21 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable

Group A-6

€ 827,-

6 days stay

  • 3 Dec 2017 up to and including 8 Dec 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable

Group B-2

€ 2.209,-

19 days stay

  • 4 Dec 2017 up to and including 22 Dec 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable

Group A-4

€ 827,-

6 days stay

  • 9 Nov 2017 up to and including 14 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group B-1

€ 2.209,-

19 days stay

  • 6 Nov 2017 up to and including 24 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A-PD1a

€ 1.127,-

6 days stay

  • 29 Nov 2017 up to and including 4 Dec 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A-PD1b

€ 1.127,-

6 days stay

  • 6 Dec 2017 up to and including 11 Dec 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Groep A-PD1f

€ 1.127,-

6 days stay

  • 12 Dec 2017 up to and including 17 Dec 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

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