Trial · NCT00149227

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

NCT00149227, Phase 4, Completed, Kyoto Prefectural University of Medicine; results first posted 2012-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study). Trials, record NCT00149227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00149227

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
NCT number: NCT00149227
Status: Completed
Phases: Phase 4
Enrollment: 3,031 participants, actual
Lead sponsor: Kyoto Prefectural University of Medicine
Conditions: Hypertension, Ischemic Heart Disease, Congestive Heart Failure, Stroke
Interventions: Valsartan, Non-ARB
First posted: 2005-09-08
Last updated: 2012-12-12
Results first posted: 2012-12-12
Limitations and caveats: The study was performed using PROBE design, which does not exclude possible bias for softer endpoints such as angina and TIA. However, all softer endpoints were diagnosed by CAG and CT/MRI. We believe that under reporting would be unlikely.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	New Onset or Recurrence of Stroke	five years	Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Primary	New Onset or Recurrence of Transient Ischemic Attack	five years	Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Primary	New Onset or Recurrence of Acute Myocardial Infarction	five years	Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
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	five years	Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
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	five years	Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Primary	Operation of PCI or Bypass Operation	five years
Primary	New Onset of Acute Dissecting Aneurysm of the Aorta	five years	Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Primary	New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans	five years	Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Primary	Transition to Dialysis, Doubling of Plasma Cr Levels	five years	The first of any events, "transition to dialysis" or "doubling of plasma Cr levels compared to the entry", occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.
Secondary	All Cause Mortality	five years

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	New Onset or Recurrence of Stroke	five years	Analyses were made by the independent Statistical Analysis Organization based on the intention-to-treat principle.	event number	NUMBER
PRIMARY	New Onset or Recurrence of Transient Ischemic Attack	five years		event number	NUMBER
PRIMARY	New Onset or Recurrence of Acute Myocardial Infarction	five years		event number	NUMBER
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	five years		event number	NUMBER
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	five years		event number	NUMBER
PRIMARY	Operation of PCI or Bypass Operation	five years		event number	NUMBER
PRIMARY	New Onset of Acute Dissecting Aneurysm of the Aorta	five years		event number	NUMBER
PRIMARY	New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans	five years		event number	NUMBER
PRIMARY	Transition to Dialysis, Doubling of Plasma Cr Levels	five years		event number	NUMBER
SECONDARY	All Cause Mortality	five years		patients	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
New Onset or Recurrence of Stroke	Valsartan	25	event number
New Onset or Recurrence of Stroke	Non-ARB	46	event number
New Onset or Recurrence of Transient Ischemic Attack	Valsartan	6	event number
New Onset or Recurrence of Transient Ischemic Attack	Non-ARB	4	event number
New Onset or Recurrence of Acute Myocardial Infarction	Valsartan	7	event number
New Onset or Recurrence of Acute Myocardial Infarction	Non-ARB	11	event number
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	Valsartan	12	event number
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	Non-ARB	26	event number
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	Valsartan	22	event number
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	Non-ARB	44	event number

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Valsartan	1,517
Overall Study	STARTED	Non-ARB	1,514
Overall Study	COMPLETED	Valsartan	1,517
Overall Study	COMPLETED	Non-ARB	1,514
Overall Study	NOT COMPLETED	Valsartan	0
Overall Study	NOT COMPLETED	Non-ARB	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Valsartan
Total, all-cause mortality	Non-ARB
Total, other adverse events	Valsartan	0	1,517
Total, other adverse events	Non-ARB	0	1,514
Total, serious adverse events	Valsartan	0	1,517
Total, serious adverse events	Non-ARB	0	1,514

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18800142	BACKGROUND	PubMed
19723695	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Valsartan vs Non-ARB: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00149227

GET https://conductscience.org/api/trials/v1/NCT00149227/registered

API reference For AI assistants