NCT00171106

Brief Summary

This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

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

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

4.7 years

First QC Date

September 10, 2005

Last Update Submit

November 16, 2016

Conditions

Diastolic Dysfunction, Symptomatic Heart Failure

Keywords

diastolic dysfunctionheart failureexercise tolerancevalsartan

Outcome Measures

Primary Outcomes (1)

  • Change in baseline exercise test after 15-42 days and 14 weeks

Secondary Outcomes (5)

  • Oxygen consumption during the exercise test

  • Exercise test blood pressure

  • Borg score of breathlessness

  • 6-minute walk test at baseline and after 14 weeks

  • Quality of life assessment at baseline and after 14 weeks

Interventions

valsartanDRUG

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic diastolic heart failure
  • Breathlessness with physical exertion

You may not qualify if:

  • Uncontrolled hypertension
  • Asthma, COPD, or abnormal lung function
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Allergy to valsartan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • Parthasarathy HK, Pieske B, Weisskopf M, Andrews CD, Brunel P, Struthers AD, MacDonald TM. A randomized, double-blind, placebo-controlled study to determine the effects of valsartan on exercise time in patients with symptomatic heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Oct;11(10):980-9. doi: 10.1093/eurjhf/hfp120.

    PMID: 19789402RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

December 1, 2002

Primary Completion

August 1, 2007

Study Completion

February 1, 2008

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

DE(1)CH(1)