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

This study has been completed.

First Received: October 14, 2005 Last Updated: June 1, 2006 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241098

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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:

MedlinePlus related topics: Heart Failure High Blood Pressure

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

Estimated Enrollment:

200

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.

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

Study ID Numbers:	CVAL489B2402
Study First Received:	October 14, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00241098 History of Changes
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:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010