Congestive Heart FailurePhase 4NCT00894868

Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

A Phase 4 study testing vildagliptin in people with Congestive Heart Failure and Type II Diabetes Mellitus, run by Novartis Pharmaceuticals at 93 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Congestive Heart Failure, Type II Diabetes Mellitus
What is being tested?: vildagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 798 participants
Where: 93 sitesin 15 countries
Study dates: May 2009to Aug 2012
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with T2DM, diagnosed at least 3 months prior to Visit 1
CHF (NYHA Class I, Class II, or Class III) at Visit 1
LVEF < 40%

Who cannot join

Pregnant or lactating female
FPG ≥ 270 mg/dL (≥15 mmol/L)

Trial locations and contacts

93 sites in 15 countries.

Country

City, postcode or hospital

93 sites in 15 countries

Russia20 sites

Novartis Investigative Site
Kaliningrad, 236016
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350072
Novartis Investigative Site
Moscow, 113093
Novartis Investigative Site
Moscow, 117997
Novartis Investigative Site
Moscow, 119048
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
Moscow, 129110
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Penza, 440026
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Saint Petersburg, 193312
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 198013
Novartis Investigative Site
Saint Petersburg, 199034
Novartis Investigative Site
Samara, 443067
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Saratov, 410031

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India13 sites

Novartis Investigative Site
Ahmedabad, Gujarat, 380014
Novartis Investigative Site
Bangalore, Karnataka, 560078
Novartis Investigative Site
Indore, Madhya Pradesh, 452010
Novartis Investigative Site
Jaipur, Rajasthan, 302001
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226003
Novartis Investigative Site
Ludhiana, Punjab, 141001
Novartis Investigative Site
Mangalore, Karnataka, 575002
Novartis Investigative Site
Nagpur, Maharashtra, 440012
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110070
Novartis Investigative Site
Secunderabad, Andhra Pradesh, 500003
Novartis Investigative Site
Trivandrum, Kerala, 695011
Novartis Investigative Site
Vadodara, Gujarat, 390015
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 530002

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Italy8 sites

Novartis Investigative Site
Bergamo, BG, 24128
Novartis Investigative Site
Florence, FI, 50143
Novartis Investigative Site
Mercato San Severino, SA, 84085
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Passirana Di Rho, MI, 20017
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Siena, SI, 53100

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Czechia7 sites

Novartis Investigative Site
Benešov, Czech Republic, 25601
Novartis Investigative Site
Broumov, 550 01
Novartis Investigative Site
Havířov, Czech Republic, 736 01
Novartis Investigative Site
Litomyšl, Czech Republic, 570 14
Novartis Investigative Site
Pardubice, 53002
Novartis Investigative Site
Prague, Czech Republic, 140 00
Novartis Investigative Site
Prague, CZE, 128 08

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Germany7 sites

Novartis Investigative Site
Alsdorf, 52477
Novartis Investigative Site
Bad Oeynhausen, 32545
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Fulda, 36037
Novartis Investigative Site
Kamp-Lintfort, 47475
Novartis Investigative Site
Saarlouis, 66740
Novartis Investigative Site
Senden, 48308

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Slovakia7 sites

Novartis Investigative Site
Banská Bystrica, 974 01
Novartis Investigative Site
Dunajská Streda, Slovak Republic, 929 01
Novartis Investigative Site
Komárno, 945 01
Novartis Investigative Site
Košice, 040 01
Novartis Investigative Site
Lučenec, 98439
Novartis Investigative Site
Modava Nad Bodvou, 045 01
Novartis Investigative Site
Nitra, Slovak Republic, 949 01

Other trials in Slovakia

Denmark6 sites

Novartis Investigative Site
Copenhagen NV, DK-2400
Novartis Investigative Site
Copenhagen S, DK-2300
Novartis Investigative Site
Frederiksberg, DK-2000
Novartis Investigative Site
Hellerup, DK-2900
Novartis Investigative Site
Roskilde, DK-4000
Novartis Investigative Site
Slagelse, DK-4200

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Estonia4 sites

Novartis Investigative Site
Pärnu, 80018
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13415
Novartis Investigative Site
Tartu, 50410

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Lithuania4 sites

Novartis Investigative Site
Alytus, LT-62381
Novartis Investigative Site
Kaunas, 50009
Novartis Investigative Site
Vilnius, LT-05261
Novartis Investigative Site
Vilnius, LT-08661

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Poland4 sites

Novartis Investigative Site
Gdansk, 80-847
Novartis Investigative Site
Kłodzko, 57-300
Novartis Investigative Site
Warsaw, 04-761
Novartis Investigative Site
Wroclaw, 50-981

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Romania4 sites

Novartis Investigative Site
Baia Mare, Maramureş, 430071
Novartis Investigative Site
Brasov, 500173
Novartis Investigative Site
Bucharest, District 2, 021382
Novartis Investigative Site
Craiova, Jud. Dolj, 200147

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Greece3 sites

Novartis Investigative Site
Alexandroupoli, GR 68100
Novartis Investigative Site
Chios, 82100
Novartis Investigative Site
Thessaloniki, 57001

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Guatemala2 sites

Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01011

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Latvia2 sites

Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Preiļi, LV-5301

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Singapore2 sites

Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 168752

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About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

Conditions: Congestive Heart Failure, Type II Diabetes Mellitus
Being tested: vildagliptin, placebo of vildagliptin
Keywords: Congestive Heart Failure, CHF, vildagliptin, metabolic disease, cardiovascular disease, T2DM
Medical subject headings: Heart Failure, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vildagliptinDrug
placebo of vildagliptinDrug

Study groups in NCT00894868
Study group	Role	What they receive
Vildagliptin	Experimental	Not described Receives: Drug: vildagliptin
Placebo	Placebo comparator	Not described Receives: Drug: placebo of vildagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).
Measured: 52 weeks

Secondary outcomes (2)

To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Measured: 52 weeks
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Aug 2012

First posted7 May 2009 (estimated)
Study startMay 2009
Primary completionAug 2012
Study completionAug 2012

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 Congestive Heart FailureStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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
Who is masked: Participant, Investigator
Enrolment: 798 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00894868
Sponsor's protocol ID: CLAF237A23118
Other IDs: 2008-005012-41, 2008
Status last verified: Apr 2014
First submitted: 6 May 2009
Last updated: 17 Dec 2020
Results posted: No

Publications

McMurray JJV, Ponikowski P, Bolli GB, Lukashevich V, Kozlovski P, Kothny W, Lewsey JD, Krum H; VIVIDD Trial Committees and Investigators. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial. JACC Heart Fail. 2018 Jan;6(1):8-17. doi: 10.1016/j.jchf.2017.08.004. Epub 2017 Oct 11.
PubMed 29032139

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
ClinicalTrials.gov ID: NCT00894868
Acronym / sponsor ID: CLAF237A23118
Conditions: Congestive Heart Failure, Type II Diabetes Mellitus
Keywords: Congestive Heart Failure, CHF, vildagliptin, metabolic disease, cardiovascular disease, T2DM
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 798 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 7 May 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vildagliptin	Experimental	Drug: vildagliptin
Placebo	Placebo comparator	Drug: placebo of vildagliptin

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with T2DM, diagnosed at least 3 months prior to Visit 1
CHF (NYHA Class I, Class II, or Class III) at Visit 1
LVEF < 40%

Key exclusion criteria (2 listed)

Pregnant or lactating female
FPG ≥ 270 mg/dL (≥15 mmol/L)

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
vildagliptin	Drug	Vildagliptin
placebo of vildagliptin	Drug	Placebo

Primary outcome

To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF).
Time frame: 52 weeks

2 secondary outcomes

To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure.
Time frame: 52 weeks
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment.
Time frame: 52 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 17 Dec 2020.
Derived from this study: PubMed 29032139McMurray JJV, Ponikowski P, Bolli GB, Lukashevich V, Kozlovski P, Kothny W, Lewsey JD, Krum H; VIVIDD Trial Committees and Investigators. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial. JACC Heart Fail. 2018 Jan;6(1):8-17. doi: 10.1016/j.jchf.2017.08.004. Epub 2017 Oct 11.
Results for CLAF237A23118 from the Novartis Clinical Trials websiteLink provided by the sponsor.

Related trials for Congestive Heart Failure

Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)

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

93 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vildagliptin in people with Congestive Heart Failure and Type II Diabetes Mellitus, run by Novartis Pharmaceuticals at 93 sites in 15 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 3 inclusion and 2 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Russia, India, Italy, Czechia, Germany and 10 more countries. 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. Some participants in this study may receive a placebo. 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?

To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). (time frame: 52 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 NCT00894868, 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 17 Dec 2020.