NCT00241098

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started May 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

October 14, 2005

Last Update Submit

October 17, 2023

Conditions

HypertensionCongestive Heart Failure

Keywords

HYPERTENSIONHEART FAILUREPEPTIDEvalsartan

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

valsartanDRUG

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Present use of ACE inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionHeart Failure

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Novartis Pharmaceutical

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

May 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

October 18, 2023

Record last verified: 2023-10