Study for patients with stable heart failure of ischemic origin

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

We are carrying out a clinical trial with an investigational drug that is being developed with the intention of treating patients with heart failure of ischemic origin (heart failure characterised by a reduced blood supply to the heart).

The main purpose of the study will be to assess how safe the study drug is and to determine how long the study drug will remain in the body. We may also study how the study drug will affect the body.

The information gathered during this clinical trial may be used to support further drug development, including larger trials in patients with heart failure.

 

In recognition of the time and effort involved in taking part in this study, you will receive £1,692 (£1,027 study payment, £505 bonus and up to £160 for travel expenses) on completion of the study provided you comply fully with all the study requirements.

 

For more information about this study:

  • You may also contact us directly; Azar Alexander-Sefre can be reached via e-mail at a.sefre@richmondpharmacology.com or via phone at +44 (0) 207 042 5800

 

Description

In recognition of the time and effort involved in taking part in this study, you will receive £1,692 (£1,027 study payment, £505 bonus and up to £160 for travel expenses) on completion of the study provided you comply fully with all the study requirements.

Details
Condition Stent, Coronary Artery Disease, Heart failure
Clinical Study IdentifierTX227267
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Coronary Artery Disease or Stent or Heart failure?
Male or female volunteers, aged between 30 and 80(inclusive)
You must be diagnosed with stable heart failure of ischaemic origin
You must have a Body Mass Index (BMI) within the range 18.0-28.0 kg/m² (inclusive)
You must have a body weight of less than or equal to 100 kg
You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse (Alcohol abuse is defined as a regular weekly intake of more than 14 units)
You must not have donated or lost blood within 16 weeks prior to first dosing
You must not be pregnant or breastfeeding
Female volunteers of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting one complete menstrual cycle prior to the first day of dosing and continuing until the follow-up visit
Male volunteers must be willing to use appropriate contraception for the duration of the study and for at least 3 months after the end of study visit. Female spouses or partners of the male volunteer must be willing to use appropriate contraception starting at least one complete menstrual cycle prior to the first day of dosing and continuing until at least 3 months after the end of study visit
You must agree not to donate sperm or ova (eggs) 3 months after end of study visit
Patients for this study are likely to be on medications including diuretics. Read here for a full overview
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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