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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Find Out Whether Valsartan With or Without Other Blood Pressure Medications Would Improve the Ability of the Heart to Fill and Empty, and the Ability of the Heart Muscle to Relax Adequately in People With High Blood Pressure.

NCT00170924

Diastolic Dysfunction Hypertension

COMPLETED PHASE4

Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

NCT00171106

Diastolic Dysfunction, Symptomatic Heart Failure

COMPLETED PHASE4

A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure

NCT00294086

Chronic Heart Failure

COMPLETED PHASE2

The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction

NCT00523549

Hypertension Diastolic Dysfunction

COMPLETED PHASE4

Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM

NCT01912534

Hypertrophic Cardiomyopathy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Congestive Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

valsartan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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