Initial Study of Fenoterol as a Treatment for Heart Failure

• Status: Completed
• Trial end date: 2014-04-15
• Target enrollment: 0
• Participant gender: All

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 help improve heart function by boosting the heart's output. Researchers have developed a different form of the drug that may be given to individuals with heart trouble. This new form needs more testing. It is especially important to compare the new form with the original form of the drug used to treat asthma.

Objectives:

• To compare how safe and effective two different forms of Fenoterol are in improving heart function.

Eligibility:

• Healthy people between 21 and 60 years of age who have no history of heart disease.

Design:

• People will be screened with a medical history, physical exam, blood and urine tests, and heart function studies.

• Those in the study will have two 36-hour inpatient study visits. At each visit, they will have a physical exam and blood and urine tests. They will fast overnight and then receive one of the two forms of Fenoterol first thing in the morning. They will not know whether they are getting the original or the modified form of the drug. After receiving the drug, they will provide frequent blood and urine samples for 24 hours. They will have a final exam before being discharged.

• Those who take part in the study will have a followup visit 5 to 7 days after the end of each study visit. They will provide more blood and urine samples and have a physical exam.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Treatments: Fenoterol

Criteria

-INCLUSION CRITERIA:

1. Healthy men and women

2. Age: 21-60

3. 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

4. BMI 24-30

5. Able to provide written informed consent

6. Agree to not participate in other clinical trials during the study period

7. 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:

1. Resting sitting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 100 bpm

2. 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.

3. Clinically significant abnormality on EKG (major Q waves, evidence of heart block, significant conduction disease, QT prolongation)

4. 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)

5. Evidence of illicit drug use or alcohol abuse

6. History of Human Immunodeficiency Virus (HIV) infection

7. History of active or chronic Hepatitis B and/or C infection

8. History of malignancy (other than non-invasive skin cancer)

9. History of coronary disease, conduction system disease, pacemaker, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, significant valvular disease, or other cardiovascular disease

10. History of asthma -- reactive airway disease

11. History of seizures or other neurologic diseases

12. History of liver or renal diseases

13. History of gastrointestinal or endocrine disorders (other than mild dyspepsia)

14. Medication use other than occasional use of over-the-counter drugs and/or contraceptives

15. Any medication or herbal drug use within the past 3 days before study participation other than contraceptives

16. Any medical history that, in the opinion of the investigator(s), will make participation of the subject in the study unsafe

17. Participation in another clinical trial involving any pharmacologic agents or blood loss within the past 30 days

18. Donation of blood or blood products within the past 56 days

19. Women who are of childbearing potential and not using acceptable forms of contraception will be excluded.