Phase 4
Completed N=3,031
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
Source: ClinicalTrials.gov NCT00149227 ↗Enrolled (actual)
3,031
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: New Onset or Recurrence of Stroke — 25; 46 event number — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Onset or Recurrence of Stroke |
25; 46 | <0.05 sig |
| PRIMARY New Onset or Recurrence of Transient Ischemic Attack |
6; 4 | — |
| PRIMARY New Onset or Recurrence of Acute Myocardial Infarction |
7; 11 | — |
| PRIMARY Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage |
12; 26 | — |
| PRIMARY Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage |
22; 44 | — |
| PRIMARY Operation of PCI or Bypass Operation |
— | — |
| PRIMARY New Onset of Acute Dissecting Aneurysm of the Aorta |
3; 5 | — |
| PRIMARY New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans |
11; 12 | — |
| PRIMARY Transition to Dialysis, Doubling of Plasma Cr Levels |
6; 14 | — |
| SECONDARY All Cause Mortality |
22; 32 | — |
| SECONDARY Worsening of Cardiac Function |
— | — |
| SECONDARY New Onset or Worsening of Arrhythmias |
— | — |
| SECONDARY New Onset or Worsening of Diabetes Mellitus or IGT |
58; 86 | — |
| SECONDARY Uncontrolled Blood Pressure, Etc. |
— | — |
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT00149227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.