Heart Failure With Reduced Ejection Fraction Clinical Trial
— TITRATIONOfficial title:
A Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients Comparing Two Titration Regimens
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
Status | Completed |
Enrollment | 498 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction = 35%; on beta blockers Exclusion Criteria: - Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bulgaria | Novartis Investigative Site | Gabrovo | |
Bulgaria | Novartis Investigative Site | Plovdiv | |
Bulgaria | Novartis Investigative Site | Plovdiv | |
Bulgaria | Novartis Investigative Site | Smolian | |
Bulgaria | Novartis Investigative Site | Sofia | |
Bulgaria | Novartis Investigative Site | Sofia | |
Finland | Novartis Investigative Site | Jyvaskyla | |
Finland | Novartis Investigative Site | Tampere | |
Germany | Novartis Investigative Site | Bad Krozingen | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin-Buch | |
Germany | Novartis Investigative Site | Dietzenbach | |
Germany | Novartis Investigative Site | Ebersbach | |
Germany | Novartis Investigative Site | Frankfurt | |
Germany | Novartis Investigative Site | Göttingen | |
Germany | Novartis Investigative Site | Hassloch | |
Germany | Novartis Investigative Site | Huy / OT Anderbeck | |
Germany | Novartis Investigative Site | Ingelheim | |
Germany | Novartis Investigative Site | Kelkheim | |
Germany | Novartis Investigative Site | Kleve | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Mainz | |
Germany | Novartis Investigative Site | Mainz | |
Germany | Novartis Investigative Site | Mühlheim | |
Germany | Novartis Investigative Site | Siegen | |
Germany | Novartis Investigative Site | Straubing | |
Germany | Novartis Investigative Site | Wuerzburg | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Debrecen | |
Hungary | Novartis Investigative Site | Mosonmagyarovar | |
Hungary | Novartis Investigative Site | Nyiregyháza | |
Hungary | Novartis Investigative Site | Pecs | |
Hungary | Novartis Investigative Site | Szekesfehervar | |
Italy | Novartis Investigative Site | Albano Laziale | RM |
Italy | Novartis Investigative Site | Aosta | AO |
Italy | Novartis Investigative Site | Bergamo | BG |
Italy | Novartis Investigative Site | Bologna | BO |
Italy | Novartis Investigative Site | Cona | FE |
Italy | Novartis Investigative Site | Cortona | AR |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | San Daniele Del Friuli | UD |
Italy | Novartis Investigative Site | Sassari | SS |
Italy | Novartis Investigative Site | Vittorio Veneto | TV |
Puerto Rico | Novartis Investigative Site | San Juan | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Brezno | Slovak Republic |
Slovakia | Novartis Investigative Site | Kosice | |
Slovakia | Novartis Investigative Site | Lucenec | |
Slovakia | Novartis Investigative Site | Nitra | Slovak Republic |
Slovakia | Novartis Investigative Site | Nove Zamky | |
Slovakia | Novartis Investigative Site | Svidnik | Slovak Republic |
Slovakia | Novartis Investigative Site | Trebisov | |
Spain | Novartis Investigative Site | A Coruna | Galicia |
Spain | Novartis Investigative Site | Almeria | Andalucia |
Spain | Novartis Investigative Site | Barcelona | Catalunya |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Malaga | Andalucia |
Spain | Novartis Investigative Site | Sanlucar de Barrameda | Andalucia |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Spain | Novartis Investigative Site | Villamartin | Cadiz |
Turkey | Novartis Investigative Site | Haydarpasa/Istanbul | |
Turkey | Novartis Investigative Site | Istanbul | |
Turkey | Novartis Investigative Site | Kocaeli | |
Turkey | Novartis Investigative Site | Mersin | |
Turkey | Novartis Investigative Site | Sivas | |
United Kingdom | Novartis Investigative Site | Bath | |
United Kingdom | Novartis Investigative Site | Bradford | |
United Kingdom | Novartis Investigative Site | Coventry | |
United Kingdom | Novartis Investigative Site | Dorchester | Dorset |
United Kingdom | Novartis Investigative Site | Gateshead | Tyne and Wear |
United Kingdom | Novartis Investigative Site | Harrow | |
United Kingdom | Novartis Investigative Site | Nuneaton | |
United Kingdom | Novartis Investigative Site | Oldham | Lancashire |
United Kingdom | Novartis Investigative Site | St Leonards on Sea | East Sussex |
United States | Novartis Investigative Site | Anaheim | California |
United States | Novartis Investigative Site | Anchorage | Alaska |
United States | Novartis Investigative Site | Atlantis | Florida |
United States | Novartis Investigative Site | Aurora | Illinois |
United States | Novartis Investigative Site | Buffalo | New York |
United States | Novartis Investigative Site | Chiefland | Florida |
United States | Novartis Investigative Site | Dallas | Texas |
United States | Novartis Investigative Site | Evansville | Indiana |
United States | Novartis Investigative Site | Gilbert | Arizona |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Houston | Texas |
United States | Novartis Investigative Site | Laurelton | New York |
United States | Novartis Investigative Site | Livingston | Texas |
United States | Novartis Investigative Site | Marion | Ohio |
United States | Novartis Investigative Site | Minneapolis | Minnesota |
United States | Novartis Investigative Site | Oak Ridge | Tennessee |
United States | Novartis Investigative Site | Peoria | Illinois |
United States | Novartis Investigative Site | Slidell | Louisiana |
United States | Novartis Investigative Site | St. Louis | Missouri |
United States | Novartis Investigative Site | Tacoma | Washington |
United States | Novartis Investigative Site | Torrance | California |
United States | Novartis Investigative Site | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Bulgaria, Finland, Germany, Hungary, Italy, Puerto Rico, Slovakia, Spain, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low) | Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving = 160 mg of valsartan or = 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients) | 12 weeks | No |
Secondary | Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low) | Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving = 160 mg of valsartan or = 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients) | 12 weeks | No |
Secondary | Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low). | Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving = 160 mg of valsartan or = 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients) | 12 weeks | No |
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