Phase 4
N=201
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
Chronic Heart Failure With Reduced Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT02768298 ↗Enrolled (actual)
201
Serious AEs
12.9%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Peak Respiratory Oxygen Uptake (VO2peak) Adjusted to Body Weight) After 3 Months of Treatment — 0.51; 0.19 mL/kg/min — p=0.2327
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LCZ696 (Drug); Enalapril (Drug); Placebo matching enalapril (Drug); Placebo matching LCZ696 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Peak Respiratory Oxygen Uptake (VO2peak) Adjusted to Body Weight) After 3 Months of Treatment |
0.51; 0.19 | 0.2327 |
| SECONDARY Change From Baseline in Peak Respiratory Oxygen Uptake (VO2peak) Adjusted to Body Weight) After 6 Weeks of Treatment |
0.28; 0.42 | 0.6247 |
| SECONDARY Change From Baseline in the Minute Ventilation (VE) to Carbon Dioxide Output Slope (VE/VCO2 Slope) |
-1.05; 0.18; 0.76; -0.07 | 0.1678 |
| SECONDARY Change From Baseline in Exercise Capacity (Watt) at Ventilatory Anaerobic Threshold (VAT) |
1.71; 0.83; 2.45; -0.83 | 0.6181 |
| SECONDARY Change From Baseline in Rate of Perceived Exertion (Perceived Dyspnea and Perceived Fatigue) During Exercise Assessed by Borg Scale |
-0.19; 0.11; -0.04; -0.20 | 0.3432 |
Summary
The purpose of the study was to determine the effect of LCZ696 vs. enalapril on improvement of exercise capacity in patients with chronic heart failure with reduced ejection fraction.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of chronic heart failure (NYHA class III) and reduced ejection fraction (LVEF ≤ 40%)
- Reduced ability to exercise, evidenced by VO2peak ≤ 18 ml/min per kg
- Patients had to be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks prior to the screening visit and until randomization visit.
Exclusion Criteria
- History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs
- Previous history of intolerance to recommended target doses of ACEIs or ARBs
- Known history of angioedema
- Requirement of treatment with both ACEIs and ARBs
- Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- Symptomatic hypotension
- Impaired renal function
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02768298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.