MedTrace Logo

Initial Study of Fenoterol as a Treatment for Heart Failure

NCT01440335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-07-05

No results posted yet for this study

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.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Oral R,R'-Fenoterol

DRUG

Oral Racemic Fenoterol

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • James B Strait, M.D. · National Institute on Aging (NIA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-10
Primary Completion
2014-04-15
Completion
2014-04-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440335 on ClinicalTrials.gov