Diastolic Dysfunction, Symptomatic Heart FailurePhase 4NCT00171106
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
A Phase 4 study testing valsartan in people with Diastolic Dysfunction, Symptomatic Heart Failure, run by Novartis at 2 sites in 2 countries.
Trial summary
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diastolic Dysfunction, Symptomatic Heart Failure
- What is being tested?
- valsartan
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2002to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Symptomatic diastolic heart failure
- Breathlessness with physical exertion
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
- Being tested
- valsartan
- Keywords
- diastolic dysfunction, heart failure, exercise tolerance, valsartan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionAug 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastolic Dysfunction, Symptomatic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171106
- Sponsor's protocol ID
- CVAL489B2401
- Status last verified
- Nov 2016
- First submitted
- 10 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT00171106
- Acronym / sponsor ID
- CVAL489B2401
- Keywords
- diastolic dysfunction, heart failure, exercise tolerance, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic diastolic heart failure
- Breathlessness with physical exertion
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
Change in baseline exercise test after 15-42 days and 14 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 19789402Parthasarathy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Diastolic Dysfunction, Symptomatic Heart Failure, run by Novartis at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline exercise test after 15-42 days and 14 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00171106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.