Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning

February 19, 2018 updated by: Yunseok Jeon, Seoul National University Hospital
Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteer
  • Not taking any medication

Exclusion Criteria:

  • BMI < 18 kg/m2 or > 30 kg/m2
  • Allergic history of any medication
  • Baseline SBP > 150 mmHg or < 100 mmHg
  • Baseline DBP > 100 mmHg or < 50 mmHg
  • Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
  • Cannot undergoing remote ischemic conditioning for any reason
  • Refuse to enroll

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta Blockers Carvedilol Phosphate

Subjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning.

Intervention: taking beta-blocker
Drug: Beta Blockers Carvedilol Phosphate
Subjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning.
No Intervention: Control
Subjects are going to undergo remote ischemic conditioning without taking any drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers
Time Frame: 24 hour after remote ischemic conditioning to healthy volunteers
Infarct size measurement after perfusing the rat heart with human serum-derived dialysate and comparison before and after remote ischemic conditioning performed to healthy volunteers
24 hour after remote ischemic conditioning to healthy volunteers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2017

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB_RIPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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