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The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00241098
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.

Condition or disease Intervention/treatment Phase
Hypertension Congestive Heart Failure Drug: valsartan Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Parallel Group Study to Evaluate the Effects of Valsartan Versus Placebo in Patients With Early Stage Heart Failure Due to Diastolic Dysfunction Already Evidenced by an Elevated B-type Natriuretic Peptide Level: the VALIDATE Study
Study Start Date : May 2003
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in a blood measurement for heart failure after 26 weeks

Secondary Outcome Measures :
  1. Change from baseline in a blood measurement for heart failure after 12 weeks
  2. Change in baseline heart size after 26 weeks
  3. Change in baseline heart size, heart function, and other parameters of diastolic heart dysfunction after 26 weeks
  4. Change from baseline in markers of heart fibrosis after 26 weeks
  5. Change from baseline quality of life questionnaire after 26 weeks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female 25-85 years of age, inclusive
  • Past diagnosis of hypertension for a min 1 year
  • Patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months
  • BP is considered adequately controlled with DBP < 90mmHg
  • Elevated BNP levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory
  • LV ejection fraction ³ 45%
  • LVH defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females
  • At least one of the following parameters of diastolic dysfunction

    • E/A < 1 for the patients who are younger than 55 years or < 0.8 for the patients whose age is ³ 55 years (full year), or
    • DT > 220 ms, or
    • IVRT > 90 ms

Exclusion Criteria:

• Present use of ACE inhibitor

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Information from the National Library of Medicine

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): NCT00241098


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241098     History of Changes
Other Study ID Numbers: CVAL489B2402
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: February 2006

Keywords provided by Novartis:
HYPERTENSION
HEART FAILURE
PEPTIDE
valsartan

Additional relevant MeSH terms:
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action