The short-term effects of sacubitril/valsartan therapy on cardiac oxygen consumption and efficiency of cardiac work in patients with heart failure and reduced systolic functio

Phase 1

• Conditions: YHA II-III heart failure and reduced systolic function; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002113-64-FI
• Lead Sponsor: ovartis Finland Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-10
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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).
11. Susceptibility to severe allergic reactions or known hypersensitivity to the active substances or to any of the excipients.
12. Intake of any medication that could affect the outcome of the study, interfere with the evaluation of the results or constitute a health risk for the study subject, as judged by the investigator.
13. Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg) in medical history.
14. Unwillingness to use adequate methods of contraception while participating in the study and for 3 months after the last administration of the PET tracer.
15. Participation in another clinical drug study within 3 months prior to the first study treatment administration of this study.
16. Prior participation in an investigational PET study or other medical or occupational exposure to significant doses of ionizing radiation, as judged by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified