Secondary Use of PARALLEL-HF Data (NCT07527767) | Clinical Trial Compass
CompletedNot Applicable
Secondary Use of PARALLEL-HF Data
Japan236 participantsStarted 2022-07-27
Plain-language summary
This study utilized the blood and first morning void (FMV) urine samples from the PARALLEL-HF study (core part). The PARALLEL-HF study (core part) was a multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to assess the effect of sacubitril valsartan at a target dose of 200 mg b.i.d. and enalapril 10 mg b.i.d. on cardiovascular (CV) mortality and morbidity in Japanese HF patients with reduced ejection fraction.
Who can participate
Age range20 Years – 89 Years
SexALL
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Inclusion criteria
✓. Written informed consent was required before any assessment could be performed.
✓. Male or female outpatients of ≥ 20 years of age (at the time of signing informed consent)
✓. Patients with a diagnosis of congestive heart failure NYHA class II-IV and reduced ejection fraction:
✓. Patients were to be on an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) at a stable dose for at least 4 weeks before Visit 1.
✓. Patients were to be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1.
✓. An aldosterone antagonist was also to be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist was to be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to Visit 1. Other evidence-based therapy for HF was also to be considered e.g., cardiac resynchronization therapy and an implantable cardioverter-defibrillator in selected patients, as recommended by guidelines.
Exclusion criteria
✕. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, ACEIs, ARBs, neutral endopeptidase (NEP) inhibitors as well as known or suspected contraindications to the study drugs.
✕. Previous documented history of intolerance to ACEIs or ARBs.
✕. Known history of angioedema.
What they're measuring
1
association between change in NYHA classification and change in plasma log BNP levels from Baseline
. 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 and/or a systolic blood pressure (SBP) \< 100 mmHg at Visit 1 (Screening) or \< 95 mmHg at Visit 199 (end of run-in).
✕. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as measured by the Japanese formula at Visit 1 (Screening) or Visit 199 (end of run-in) or \> 35% decline in eGFR between Visit 1 and Visit 199 (according to local measurements).
✕. Serum potassium \> 5.2 mmol/L (mEq/L) at Visit 1 (Screening) or \> 5.4 mmol/L (mEq/L) at Visit 199 (end of run-in) (according to local measurements).