To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.
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ClinicalTrials.gov Identifier: NCT00170924 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
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Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.
This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diastolic Dysfunction Hypertension | Drug: Valsartan | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 317 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

- Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
- Change from baseline in the wall thickness of left heart ventricle after 38 weeks
- Change from baseline in the size (mass) left heart ventricle after 38 weeks
- Change from baseline in heart function after 38 weeks
- Change from baseline in circulating marker of ventricular function after 38 weeks
- Change from baseline in circulating marker of inflammation

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Diagnosis/History of high blood pressure
- Male or Female age 45 years or older
Exclusion Criteria:
- History of stroke, transient ischemic attack or heart attack within the last 6 months
- A hospital admission for congestive heart failure within the last year
- Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.
Other protocol-defined exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170924
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00170924 |
Other Study ID Numbers: |
CVAL489AUS52 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | November 8, 2011 |
Last Verified: | November 2011 |
Hypertension, High Blood Pressure, Diastolic Dysfunction, Heart Disease |
Hypertension Vascular Diseases Cardiovascular Diseases Valsartan |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |