Controlled trial on the short-term effects of sacubitril/valsartan therapy on cardiac oxygen consumption and efficiency of cardiac work in patients with NYHA II-III heart failure and reduced systolic function using 11C-acetate positron emission tomography and echocardiography

ovartis Finland Oy0 sites60 target enrollmentOctober 10, 2017

DrugsEntresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets Diovan 80 mg film-coated tablets Diovan 160 mg film-coated tablets

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Finland Oy
Enrollment: 60
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 10, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Finland Oy

Eligibility Criteria

Inclusion Criteria

•1\. Voluntary, valid written informed consent (IC) obtained before any study\-related assessment is performed.
•2\. Sufficient command of the Finnish or Swedish language to be able to fully understand the ICF and other study information and to be able to communicate with the study personnel.
•3\. Male and female subjects \=40 and \=80 years of age.
•4\. Documented chronic HF with left ventricle EF 25\-35% and NYHA class II\-III symptoms.
•5\. Systolic BP 110\-160 mmHg at the time of randomization.
•6\. Optimal standard HF therapy according to ESC guidelines, including at a minimum beta\-blockers in all subjects, at a stable dose for at least 4 weeks before the first screening visit.
•7\. Valsartan treatment tolerated at a dose of 80 mg or 160 mg BID for at least 4 weeks during the screening/run\-in period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\. Predicted poor compliance or inability to communicate well with the investigator or the study center personnel.
•2\. Current acute or subacute decompensated HF.
•3\. Presence of acute coronary syndrome, stroke, transient ischemic attack or other major cardiovascular event or cardiovascular procedure within 3 months before screening.
•4\. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after randomization.
•5\. Evidence of clinically significant renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic\-endocrine, neurological, urogenital or psychiatric disease that may constitute a health risk for the subject and/or would interfere with the evaluation of the results, as judged by the investigator.
•6\. Symptomatic hypotension that persists even after modification of concomitant medication(s), at any time during the screening/run\-in period.
•7\. Estimated glomerular filtration rate (eGFR) \< 45 ml/min at any time during the screening/run\-in period that persists even after modification of concomitant medication(s).
•8\. Serum potassium \>5\.2 mmol/l at any time during the screening/run\-in period that persists even after modification of concomitant medication(s).
•9\. Serum creatinine \> 1\.5 x ULN (upper limit of normal) at any time during the screening/run\-in period that persists even after modification of concomitant medication(s).
•10\. Contraindication to neprilysin inhibitor or ARB (such as previous angioedema or known intolerance).