MedDataX Logo

Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)

NCT ID: NCT00149227

Last Updated: 2012-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3031 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

High risk hypertension Ischemic heart disease Angiotensin receptor blockers Cardiovascular mortality- morbidity KYOTO HEART Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-ARB

'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs

Group Type ACTIVE_COMPARATOR

Non-ARB

Intervention Type DRUG

'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

Valsartan

Valsartan add-on treatment

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valsartan

Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary.

Intervention Type DRUG

Non-ARB

'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diovan Conventional anti-hypertensive treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of hypertension
* Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI\>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH)

Exclusion Criteria

* Patients who have already been administered ARB
* Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)
* Severe/malignant/secondary hypertensive patients
* Pregnant women and women of childbearing potential
* History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months
* Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block
* Severe renal impairment (Serum creatinine \>3.0 mg/dl)
* Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyoto Prefectural University of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hiroaki Matsubara, MD., PhD

Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hiroaki Matsubara, MD,PhD

Role: STUDY_CHAIR

Kyoto Prefectural University of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Sawada T, Takahashi T, Yamada H, Dahlof B, Matsubara H; KYOTO HEART Study Group. Rationale and design of the KYOTO HEART study: effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high risk of cardiovascular events. J Hum Hypertens. 2009 Mar;23(3):188-95. doi: 10.1038/jhh.2008.116. Epub 2008 Sep 18.

Reference Type BACKGROUND
PMID: 18800142 (View on PubMed)

Sawada T, Yamada H, Dahlof B, Matsubara H; KYOTO HEART Study Group. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study. Eur Heart J. 2009 Oct;30(20):2461-9. doi: 10.1093/eurheartj/ehp363. Epub 2009 Aug 31.

Reference Type RESULT
PMID: 19723695 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KHS2004

Identifier Type: -

Identifier Source: org_study_id