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CompletedNCT00171106Updated Nov 18, 2016

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

A Phase 4 interventional study of valsartan in Diastolic Dysfunction, Symptomatic Heart Failure, sponsored by Novartis. Completed at 2 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diastolic Dysfunction, Symptomatic Heart Failure

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Keywords

  • diastolic dysfunction
  • heart failure
  • exercise tolerance
  • valsartan
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 150 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.

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Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Symptomatic diastolic heart failure
  • Breathlessness with physical exertion

Exclusion criteria

Exclusion Criteria:

  • 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

Other protocol-defined exclusion criteria may apply

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
150 participants

Interventions

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Oxygen consumption during the exercise test

  2. Exercise test blood pressure

  3. Borg score of breathlessness

  4. 6-minute walk test at baseline and after 14 weeks

  5. Quality of life assessment at baseline and after 14 weeks

07

Study locations

2 sites
  • Investigative Centers, Germany
  • Novartis Pharmaceuticals
    Basel, Switzerland
08

References and documents

Publications

  • 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. PubMed 19789402 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2002, a primary completion of Aug 2007 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2005
First posted
Sep 15, 2005
Start
Dec 2002
Primary completionActual
Aug 2007
CompletionActual
Feb 2008
Last update
Nov 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00171106
Lead sponsor
Novartis
First posted
Sep 15, 2005
Start date
Dec 2002
Primary completion
Aug 2007
Completion
Feb 2008
Last update
Nov 18, 2016

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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