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

Primary Purpose

Dilated Cardiomyopathy

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

FDG PET

About this trial

This is an interventional other trial for Dilated Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

dilated cardiomyopathy

Exclusion Criteria:

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

Sites / Locations

Department of Internal Medicine,Dong-A University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olmesartan group

Valsartan group

Arm Description

olmesartan 20mg once daily with rosuvastatin 5mg once a day for 6-month

valsartan 40mg twice daily with rosuvastatin 5mg once a day for 6-month

Outcomes

Primary Outcome Measures

Rate of glucose metabolism

data from fludeoxyglucose positron emission tomography

Secondary Outcome Measures

Full Information

NCT ID

NCT04174456

First Posted

November 18, 2019

Last Updated

August 22, 2020

Sponsor

Dong-A University

1. Study Identification

Unique Protocol Identification Number

NCT04174456

Brief Title

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

Official Title

Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dilated Cardiomyopathy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Olmesartan group

Arm Type

Experimental

Arm Description

olmesartan 20mg once daily with rosuvastatin 5mg once a day for 6-month

Arm Title

Valsartan group

Arm Type

Active Comparator

Arm Description

valsartan 40mg twice daily with rosuvastatin 5mg once a day for 6-month

Intervention Type

Diagnostic Test

Intervention Name(s)

FDG PET

Intervention Description

baseline and 6-month follow-up FDG PET

Primary Outcome Measure Information:

Title

Rate of glucose metabolism

Description

data from fludeoxyglucose positron emission tomography

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: dilated cardiomyopathy Exclusion Criteria: contraindication to angiotensin receptor blocker cardiogenic shock sensitive to rosuvastatin liver cirrhosis more than Child class B

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kyung-Mi Ko

Phone

82-51-240-5740

kkmcrc@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyungil PARK

Organizational Affiliation

Dong-A University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Internal Medicine,Dong-A University College of Medicine

City

Busan

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kyungil Park, MD

Phone

82-51-240-2733

sotier@dau.ac.kr

First Name & Middle Initial & Last Name & Degree

Sua Jo, MD

Phone

82-10-3900-9713

flysofina@gmail.com

First Name & Middle Initial & Last Name & Degree

Chang-Bae Sohn, MD

First Name & Middle Initial & Last Name & Degree

Jeonghwan Kim, MD

First Name & Middle Initial & Last Name & Degree

Yong-Seop Kwon, MD, PhD

First Name & Middle Initial & Last Name & Degree

Su Hong Kim, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kyungil Park, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

35033178

Citation

Jo S, Moon H, Park K, Sohn CB, Kim J, Kwon YS, Kim SH. Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial. Trials. 2022 Jan 15;23(1):36. doi: 10.1186/s13063-021-05970-7.

Results Reference

derived

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

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