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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00241098
First received: October 14, 2005
Last updated: November 7, 2011
Last verified: February 2006
History of Changes
  Purpose

This is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.


Condition Intervention Phase
Hypertension
Congestive Heart Failure
 Drug: valsartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Enrollment: 37
Study Start Date: May 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241098

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241098     History of Changes
Other Study ID Numbers: CVAL489B2402
Study First Received: October 14, 2005
Last Updated: November 7, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:
HYPERTENSION
HEART FAILURE
PEPTIDE
valsartan

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Natriuretic Peptide, Brain
Valsartan
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013