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

K

Kyoto Prefectural University of Medicine

Status and phase

Completed
Phase 4

Conditions

Ischemic Heart Disease
Hypertension
Stroke
Congestive Heart Failure

Treatments

Drug: Non-ARB
Drug: Valsartan

Study type

Interventional

Funder types

Other

Identifiers

NCT00149227
KHS2004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3,031 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,031 participants in 2 patient groups

Non-ARB
Active Comparator group
Description:
'Non-ARB' was defined as Conventional anti-hypertensive treatment except for ARB and ACEIs
Treatment:
Drug: Non-ARB
Valsartan
Experimental group
Description:
Valsartan add-on treatment
Treatment:
Drug: Valsartan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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