Overview

Effects of Esmolol Infusion on Hemodynamic Responses to Isometric Handgrip

Status:
Withdrawn
Trial end date:
2023-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study will test the hypothesis that Esmolol hydrochloride, a beta-1 selective blocker, improves myocardial oxygen (O2) supply-demand balance at rest and during isometric (handgrip) stress in adults with peripheral artery disease (PAD) and healthy controls.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
David N. Proctor, PhD
Treatments:
Esmolol
Criteria
Inclusion Criteria:

- Patients with peripheral arterial disease (PAD)

1. Capable of giving informed consent

2. Men and women age 21-85 years

3. Diagnosed with PAD (i.e., ankle-brachial index below 0.9)

4. Fontaine stage II or less - no pain while resting

5. Satisfactory history and physical exam

6. Fluent in written and spoken English

Healthy adults without PAD

1. Capable of giving informed consent

2. Men and women age 21-85 years

3. Satisfactory medical history and physical exam, as determined by study physician

4. Not currently taking medications affecting heart rate or contractility (confirmed by
study physician)

5. Fluent in written and spoken English

Exclusion Criteria:

Participants who will not be studied are those who:

1. Are less than 21 years of age

2. Are females who are pregnant or lactating

3. Are prisoners or institutionalized individuals or unable to consent

4. Diagnosed renal failure (Creatinine >2.0 mg/dl)

5. Diagnosed liver disease (ALT and AST 2 times normal)

6. Have uncontrolled diabetes

7. Have uncontrolled hypertension

8. Have a left ventricular ejection fraction < 40%

9. Have a recent history of unstable angina or myocardial infarction (<6 months),
unstable angina, or use of nitrate medications within past 2 weeks

10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)

11. Diagnosed bleeding or clotting disorder or recent blood transfusion

12. Have asthma, history of thyroid issues or hyperkalemia