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.

NCT00170924 | Completed Phase 4

• 1 other identifier: CVAL489AUS52
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastolic Dysfunction; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

Valsartan DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis/History of high blood pressure
• Male or Female age 45 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• Solomon SD, Janardhanan R, Verma A, Bourgoun M, Daley WL, Purkayastha D, Lacourciere Y, Hippler SE, Fields H, Naqvi TZ, Mulvagh SL, Arnold JM, Thomas JD, Zile MR, Aurigemma GP; Valsartan In Diastolic Dysfunction (VALIDD) Investigators. Effect of angiotensin receptor blockade and antihypertensive drugs on diastolic function in patients with hypertension and diastolic dysfunction: a randomised trial. Lancet. 2007 Jun 23;369(9579):2079-87. doi: 10.1016/S0140-6736(07)60980-5.

  PMID: 17586303 DERIVED

Related Links

• Novartis Patient Recruitment Website

MeSH Terms

Conditions

Hypertension; Heart Diseases

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

US (1)