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Completed

NCT Number: NCT00241098

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Congestive Heart Failure Heart Diseases Heart Failure Vascular Diseases

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline in a blood measurement for heart failure after 26 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 18, 2005
Registry last updated
Oct 18, 2023

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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