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CompletedNCT07527767Updated Apr 14, 2026

Secondary Use of PARALLEL-HF Data

An observational study in Chronic Heart Failure and Reduced Ejection Fraction (HFrEF), sponsored by Novartis Pharmaceuticals. Completed at 1 site in Japan. Open to participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Novartis Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
236
Ages
20 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Keywords

  • Secondary use
  • Sacubitril Valsartan
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Data related to biomarkers and clinical assessment in the PARALLEL-HF study

Inclusion criteria

  1. Written informed consent was required before any assessment could be performed.
  2. Male or female outpatients of ≥ 20 years of age (at the time of signing informed consent)
  3. Patients with a diagnosis of congestive heart failure NYHA class II-IV and reduced ejection fraction:

    • LVEF ≤ 35% at Visit 1
    • NT-proBNP ≥ 600 pg/mL at Visit 1 OR NT-proBNP ≥ 400 pg/mL at Visit 1 and a hospitalization for HF within the previous 12 months
  4. 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.
  5. 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.
  6. 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

Exclusion Criteria:

  1. 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.
  2. Previous documented history of intolerance to ACEIs or ARBs.
  3. Known history of angioedema.
  4. Requirement of treatment with both ACEIs and ARBs.
  5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
  6. 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).
  7. 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).
  8. 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).
  9. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.
  10. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
  11. Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to Visit 1 or intent to implant such a device. Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before Visit 1 are excluded.
  12. History of severe pulmonary disease.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
236 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. association between change in NYHA classification and change in plasma log BNP levels from Baseline

    In this study, response variable change from Baseline in NYHA class was grouped into 3 categories: improved=3 unchanged=2 and worsened=1. An ordinal logistic regression model was used to assess the relationship between change from Baseline in NYHA classification and log-transformed change from Baseline of (BNP).

    Time frame: Baseline, Month 6, Week 0, Week 4 and Week 8

Secondary outcomes

  1. association between the change in NYHA classification and log-transformed biomarkers from Baseline to pre-defined time points in patients treated with either sacubitril valsartan or enalapril

    The response variable was the change from baseline in NYHA class (expressed as improved, unchanged, worsened). The model included baseline NYHA class as fixed effects and log-transformed change from baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) at any scheduled timepoints as covariates.

    Time frame: Week 0, Week 4, Week 8, Month 6

  2. association between the change in KCCQ-CSS and log-transformed biomarkers from Baseline to pre-defined time points in patients treated with either sacubitril valsartan or enalapril

    The binary response analysis was performed using a generalized mixed model with baseline KCCQ-CSS as fixed effects and log-transformed change from baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) as covariates.

    Time frame: Week 0, Week 4, Week 8, Month 6

  3. association between the change in NYHA classification from Baseline to pre-defined time points and Baseline of log-transformed biomarkers in patients treated with either sacubitril valsartan or enalapril.

    The response variable is the change from baseline in NYHA class (expressed as improved, unchanged, worsened). The model includes baseline NYHA class as fixed effects and log-transformed baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTnT, Cys-C, PRA, NT-proBNP, hsCRP) at any scheduled timepoints as covariates.

    Time frame: Week 0, Week 4, Week 8, Month 6

  4. association between the change in KCCQ from Baseline to pre-defined time points and Baseline of log-transformed biomarkers in patients treated with either sacubitril valsartan or enalapril.

    The binary response analysis is performed using a generalized mixed model with baseline KCCQ-OSS as fixed effects and log-transformed baseline of biomarkers (BNP, cGMP, UACR, aldosterone, hsTNT, Cys-C, PRA, NT-proBNP, hsCRP) as covariates

    Time frame: Week 0, Week 4, Week 8, Month 6

  5. change in log-transformed biomarkers from baseline to pre-defined time points

    Time frame: Week 0, Week 4, Week 8, Month 6

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Study locations

1 site
  • Novartis Investigative SIte
    Tokyo, Tokyo 105-6333, Japan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07527767
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Jul 27, 2022
Primary completion
Dec 15, 2023
Completion
Dec 15, 2023
Last update
Apr 14, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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