Current partner codePEPTIDESDE
NCT00241098·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

37

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

valsartan

Timeline

From registration to results.

  1. First posted

    Oct 18, 2005

  2. Study start

    May 2003

  3. Primary completion

    Jun 2005

  4. Study completion

    Jun 2005

  5. Results posted

    Not reported

  6. Registry updated

    Oct 18, 2023

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

Eligibility

Who can take part.

Minimum age
25 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

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. \-

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Nesiritide.

Related PeptideStat pages

Put the record in context.

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