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.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170924

Enrollment

317

Registered

2005-09-15

Start date

2004-08-31

Completion date

2006-06-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Hypertension

Keywords

Hypertension, High Blood Pressure, Diastolic Dysfunction,, Heart Disease

Brief summary

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.

Interventions

DRUGValsartan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026