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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014