Patients with Heart Failure and currently on a loop diuretic

  • STATUS
    Recruiting
Updated on 23 November 2020
heart failure
fatigue
furosemide

Summary

The purpose of this study is to evaluate the action of the study drug on your kidneys and your ability to eliminate salt and water alongside a diuretic (furosemide).

The information gathered during this clinical trial may support further drug development, including larger trials in patients with heart failure.  The study drug is being developed with the intention of treating patients with heart failure.

Heart failure is a long-term illness where the heart has been damaged and does not pump blood through the body as well as it should. Symptoms of heart failure can include shortness of breath (dyspnoea), lack of energy (fatigue), build-up of fluid (oedema), chronic coughing/wheezing and confusion.

 

In recognition of the time and effort involved in taking part in this study, you will receive £994 (£644 study payment, £300 bonus and £50 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 £994 (£644 study payment, £300 bonus and £50 for travel expenses) on completion of the study provided you comply fully with all the study requirements.

Details
Condition Heart failure, Cardiomyopathy, Congestive Heart Failure
Clinical Study IdentifierTX227268
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female volunteers aged 18 or older (inclusive)
You must have a body weight of between 45 kg (inclusive) and 140 kg (exclusive)
You must be diagnosed with stable heart failure with reduced ejection fraction (reduced total amount of blood ejected from the heart)
You must not test positive for, 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 be pregnant or breastfeeding
Female volunteers of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting the first day of dosing and continuing until at least 30 days after last study drug administration
Male volunteers must be willing to use appropriate contraception for the duration of the study and for at least 90 days after last study drug administration
Female spouses or partners of the male volunteer must be willing to use appropriate contraception for the duration of the study for at least 90 days after last study drug administration of male volunteer
You must agree not to donate sperm for the duration of the study for at least 90 days after last study drug administration
Patients for this study are likely to be on medications including loop 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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