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Beta Blockers
Beta Blockers for Heat Stress
Phase 4
Recruiting
Led By Craig Crandall, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Healthy and free of any significant medical problems
* 65+ years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuously throughout the 3-hour heat exposure.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
"This trial will investigate if the drugs propranolol and metoprolol cause older adults to have higher body temperatures when exposed to extreme heat for 3 hours."
Who is the study for?
This trial is for healthy older adults aged 65 and over with normal heart rhythms, cholesterol under 200 mg/dl, and blood pressure below 140/90 mmHg. Participants should not have significant medical issues.
What is being tested?
The study investigates how two heart medications, propranolol and metoprolol, affect the body's core temperature during extreme heat exposure for three hours in older individuals.
What are the potential side effects?
Potential side effects may include increased body temperature during heat exposure when taking propranolol or metoprolol. These drugs can also cause dizziness, fatigue, or a slower heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy with no major medical issues.
Select...
I am 65 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuously throughout the 3-hour heat exposure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuously throughout the 3-hour heat exposure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Internal temperature
Whole body sweat rate
Secondary study objectives
Arterial blood pressure
Heart rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Propranolol, then Placebo, then MetoprololExperimental Treatment1 Intervention
Group II: Propranolol, then Metoprolol, then PlaceboExperimental Treatment1 Intervention
Group III: Placebo, then Propranolol, then MetoprololExperimental Treatment1 Intervention
Group IV: Placebo, then Metoprolol, then PropranololExperimental Treatment1 Intervention
Group V: Metoprolol, then Propranolol, then PlaceboExperimental Treatment1 Intervention
Group VI: Metoprolol, then Placebo, then PropranololExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,661 Total Patients Enrolled
10 Trials studying Aging
564 Patients Enrolled for Aging
Craig Crandall, PhDPrincipal InvestigatorUniv of Texas Southwestern Med Ctr