Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy

August 22, 2020 updated by: Kyungil Park, Dong-A University

Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy

The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Myocardial viability plays an important role in improving the function of the heart. To date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability.

Olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. Research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. In addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. However, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified.

The purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Department of Internal Medicine,Dong-A University College of Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chang-Bae Sohn, MD
        • Sub-Investigator:
          • Jeonghwan Kim, MD
        • Sub-Investigator:
          • Yong-Seop Kwon, MD, PhD
        • Sub-Investigator:
          • Su Hong Kim, MD, PhD
        • Principal Investigator:
          • Kyungil Park, MD, PhD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • dilated cardiomyopathy

Exclusion Criteria:

  • contraindication to angiotensin receptor blocker
  • cardiogenic shock
  • sensitive to rosuvastatin
  • liver cirrhosis more than Child class B

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olmesartan group
olmesartan 20mg once daily with rosuvastatin 5mg once a day for 6-month
Diagnostic test: FDG PET
baseline and 6-month follow-up FDG PET
Active Comparator: Valsartan group
valsartan 40mg twice daily with rosuvastatin 5mg once a day for 6-month
Diagnostic test: FDG PET
baseline and 6-month follow-up FDG PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of glucose metabolism
Time Frame: 6 month
data from fludeoxyglucose positron emission tomography
6 month

Collaborators and Investigators

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

Sponsor

Dong-A University

Investigators

  • Study Director: Kyungil PARK, Dong-A University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We don't have any plan to make individual participant data (IPD) available to other researchers

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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