Clinical trial NCT03066804: A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
Official title: A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: Cardiovascular Diseases
Heart Failure
Heart failure with Preserved Ejection Fraction
NT-proBNP
6 MWT
KCCQ
SF-36
NYHA Class
LCZ696
Enalapril
Valsartan
Angiotensin-Converting Enzyme Inhibitors (ACEi)
Angiotensin II Type 1 Receptor Blockers (ARB)
Renin Angiotensin System Inhibitors (RASi)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 2572
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Detailed description: This study was a 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate sacubitril/valsartan compared to individualized medical therapy on NT proBNP, exercise capacity, symptoms and QoL in patients with heart failure and preserved left ventricular ejection (HFpEF) fraction (LVEF \> 40%). Patients were initially stratified into one of three strata according to prior treatment for comorbidities: Angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or no prior renin angiotensin system inhibitors (RASi). Patients in each stratum were randomized in a 1:1 ratio and received either sacubitril/valsartan or comparator (i.e.

enalapril for patients in ACEi strata, valsartan for patients in the ARB strata and placebo for patients in the No RASi strata). There was no designated proportion of patients planned in each stratum; the strata were populated based upon the patient's prior treatment regimen. The study consisted of a screening epoch of up to 2 weeks and a randomized treatment epoch of 24 weeks, which included a 1 to 4 week study drug up-titration epoch followed by a 20 to 23 week maintenance epoch. Uptitration to target doses was recommended to occur within the first four weeks of the study, and was performed by Investigator's discretion based on the patient's clinical status.

Eligibility criteria: Inclusion Criteria:

* Left ventricular ejection fraction (LVEF) \>40% by echo within 6 months prior to study entry or during the screening epoch
* Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist \[MRAs\]) for at least 30 days prior to study entry
* NYHA class II-IV
* Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
* NT-proBNP \> 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or \>600 pg/mL for patients with AF
* KCCQ clinical summary score \< 75
* Patients on ACEi or ARB therapy must have a history of HTN

Exclusion Criteria:

* Any prior measurement of LVEF ≤ 40%, under stable conditions
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
* Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft \[CABG\]), unless an echo measurement was performed after the event confirming the LVEF to be \>40%
* Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
* Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
* History of hypersensitivity to LCZ696 or its components
* Patients with a known history of angioedema
* Walk distance primarily limited by non-cardiac comorbid conditions at study entry
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dL males and \< 9.5 g/dL females, or body mass index (BMI) \> 40 kg/m\^2.
* Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP \>150 mmHg and \<180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP \< 110 mmHg at study entry.
* Patients with HbA1c \> 7.5% not treated for diabetes
* Patients with prior major organ transplant or intent to transplant (ie on transplant list)
* eGFR \< 30 ml/min/1.73 m\^2 as measured by MDRD at screening
* Serum potassium \> 5.2 mmol /L (or equivalent plasma potassium value) at study entry
* History or presence of any other disease with a life expectancy of \< 3 years
* Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12
timeFrame: Baseline, week 12
measure: Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24
timeFrame: Baseline, week 24
Secondary outcomes:
measure: Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in NYHA Functional Class at Week 24
timeFrame: Baseline, week 24
measure: Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
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country: Netherlands
facility: Novartis Investigative Site
city: Trujillo
country: Peru
facility: Novartis Investigative Site
state: La Libertad
city: Cercado De Lima
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Borja
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Miguel
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Callao
country: Peru
facility: Novartis Investigative Site
city: Braga
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Penafiel
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Viana do Castelo
country: Portugal
facility: Novartis Investigative Site
city: Vila Real
country: Portugal
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 4
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Bacau
country: Romania
facility: Novartis Investigative Site
city: Baia Mare
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Pitesti
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Tirgoviste
country: Romania
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Gatchina
country: Russian Federation
facility: Novartis Investigative Site
city: Ivanovo
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: Nizhnii Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov on Don
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov on Don
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: 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: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tyumen
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Kragujevac
country: Serbia
facility: Novartis Investigative Site
city: Niska Banja
country: Serbia
facility: Novartis Investigative Site
city: Nis
country: Serbia
facility: Novartis Investigative Site
city: Sremska Kamenica
country: Serbia
facility: Novartis Investigative Site
city: Namestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Presov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Handlova
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Dolny Kubin
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novartis Investigative Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Povazska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Snina
country: Slovakia
facility: Novartis Investigative Site
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Huelva
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Puerto Real
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Villamartin
country: Spain
facility: Novartis Investigative Site
state: Cadiz
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: Torrevieja (Alicante)
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: San Sebastian de los Reyes
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murcia
city: Manises
country: Spain
facility: Novartis Investigative Site
state: Valencia
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Las Palmas De Gran Canarias
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Ubon Ratchathani
country: Thailand
facility: Novartis Investigative Site
city: Eskisehir
country: Turkey
facility: Novartis Investigative Site
state: Meselik
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kocaeli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Sivas
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
city: High Wycombe
country: United Kingdom
facility: Novartis Investigative Site
state: Buckinghamshire
city: Stockton on Tees
country: United Kingdom
facility: Novartis Investigative Site
state: Cleveland
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
state: Derbyshire
city: Craigavon
country: United Kingdom
facility: Novartis Investigative Site
state: Northern Ireland
city: Wansford
country: United Kingdom
facility: Novartis Investigative Site
state: Peterborough
city: Addlestone
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
state: Tyne And Wear
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.