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OpenTrials
Completed

NCT Number: NCT00170924

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.

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.

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Key information

Conditions

Diastolic Dysfunction Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram

Secondary outcomes

  1. Change from baseline in the wall thickness of left heart ventricle after 38 weeks

  2. Change from baseline in the size (mass) left heart ventricle after 38 weeks

  3. Change from baseline in heart function after 38 weeks

  4. Change from baseline in circulating marker of ventricular function after 38 weeks

  5. Change from baseline in circulating marker of inflammation

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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