Clinical trial NCT00894868: Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Type II Diabetes Mellitus
Keywords: Congestive Heart Failure
CHF, vildagliptin
metabolic disease
cardiovascular disease
T2DM
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

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

Primary outcomes:
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).
timeFrame: 52 weeks
Secondary outcomes:
measure: 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.
timeFrame: 52 weeks
measure: 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.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Benesov
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Havirov
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Litomysl
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Broumov
country: Czechia
facility: Novartis Investigative Site
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen NV
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen S
country: Denmark
facility: Novartis Investigative Site
city: Frederiksberg
country: Denmark
facility: Novartis Investigative Site
city: Hellerup
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Slagelse
country: Denmark
facility: Novartis Investigative Site
city: Pärnu
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Alsdorf
country: Germany
facility: Novartis Investigative Site
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Kamp-Lintfort
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Senden
country: Germany
facility: Novartis Investigative Site
city: Alexandroupolis
country: Greece
facility: Novartis Investigative Site
city: Chios
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Secunderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Vishakhapatnam
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Vadodara
country: India
facility: Novartis Investigative Site
state: Gujrat
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Trivandrum
country: India
facility: Novartis Investigative Site
state: Kerala
city: Indore
country: India
facility: Novartis Investigative Site
state: Madhya Pradesh
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Ludhiana
country: India
facility: Novartis Investigative Site
state: Punjab
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Passirana Di Rho
country: Italy
facility: Novartis Investigative Site
state: MI
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Mercato San Severino
country: Italy
facility: Novartis Investigative Site
state: SA
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Novara
country: Italy
facility: Novartis Investigative Site
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Preili
country: Latvia
facility: Novartis Investigative Site
city: Alytus
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Klodzko
country: Poland
facility: Novartis Investigative Site
city: Warsawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 2
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud. Dolj
city: Baia-Mare
country: Romania
facility: Novartis Investigative Site
state: Maramures
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Kaliningrad
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnodar
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Penza
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Dunajska Streda
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Komarno
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Modava Nad Bodvou
country: Slovakia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.