Status:
COMPLETED
Initial Study of Fenoterol as a Treatment for Heart Failure
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
Brief Summary
Background: \- Fenoterol has been used to treat asthma by opening up the airways in the lungs. It also increases the heart rate without significantly increasing blood pressure. This means that it may...
Detailed Description
Fenoterol is a drug that has been used for the treatment of disease like asthma for many years. It is available in Canada in an inhaled form where it is called Berotec . Fenoterol stimulates receptors...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy men and women
- Age: 21-60
- Screening laboratory evaluations with no clinically significant abnormal results:
- Chem-20 panel plus troponin
- Complete blood count with differential and platelet count
- Urinalysis with microscopic examination
- Electrocardiogram
- Echocardiogram: 2D + Doppler
- Urine drug screen
- Urine pregnancy test
- BMI 24-30
- Able to provide written informed consent
- Agree to not participate in other clinical trials during the study period
- If in child-bearing age and participating in sexual activity that could lead to pregnancy, agree to use a medically accepted method of contraception for a woman for at least 1 month prior to enrollment and continuing 1 month after completion of the fifth study visit, and for a man beginning immediately after the second study visit and continuing for 3 months after completion of the fifth study visit.
- EXCLUSION CRITERIA:
- Resting sitting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 100 bpm
- Abnormal laboratory examination (ALT and AST greater than 1.5 times the normal range, other labs within 10% of normal range); abnormal troponin screening level will be an exclusion.
- Clinically significant abnormality on EKG (major Q waves, evidence of heart block, significant conduction disease, QT prolongation)
- Clinically significant abnormality on Echocardiogram (ejection fraction less than 50 percent, valvular heart disease of moderate severity, pulmonary hypertension with PASP greater than 40mm Hg)
- Evidence of illicit drug use or alcohol abuse
- History of Human Immunodeficiency Virus (HIV) infection
- History of active or chronic Hepatitis B and/or C infection
- History of malignancy (other than non-invasive skin cancer)
- History of coronary disease, conduction system disease, pacemaker, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, significant valvular disease, or other cardiovascular disease
- History of asthma -- reactive airway disease
- History of seizures or other neurologic diseases
- History of liver or renal diseases
- History of gastrointestinal or endocrine disorders (other than mild dyspepsia)
- Medication use other than occasional use of over-the-counter drugs and/or contraceptives
- Any medication or herbal drug use within the past 3 days before study participation other than contraceptives
- Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe
- Participation in another clinical trial involving any pharmacologic agents or blood loss within the past 30 days
- Donation of blood or blood products within the past 56 days
- Women who are of childbearing potential and not using acceptable forms of contraception will be excluded.
Exclusion
Key Trial Info
Start Date :
July 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01440335
Start Date
July 10 2011
End Date
April 15 2014
Last Update
July 5 2018
Active Locations (1)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224