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The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients (TurkuPET)

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ClinicalTrials.gov Identifier: NCT03300427
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study will assess the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on cardiac oxygen consumption and the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: sacubitril/valsatran Drug: valsartan Drug: placebo to valsartan Drug: placebo to sacubitril/valsartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : December 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sacubitril/valsartan
Participants will be randomized to two treatment arms in a 1:1, double blinded fashion. Two strengths of sacubitril/valsartan will be available for use after randomization, 49 mg sacubitril/51 mg valsartan and 97 mg sacubitril/103 mg valsartan. After randomization, subjects in this arm will receive sacubitril/valsartan 100 mg orally twice daily (BID). The dose will be then up-titrated to 200 mg BID (or maintained at the starting dose level, if up-titration is not possible). Dose modifications are allowed until week 4 after the randomization. In order to be eligible for the final assessments, the subject has to tolerate the 100 mg BID dose at the minimum. In total, participants will be on sacubitril/valsartan for a minimum of 8 weeks and a maximum of 10 weeks.
Drug: sacubitril/valsatran
sacubitril/valsatran 100 or 200 mg BID

Drug: placebo to valsartan
placebo to valsartan 80 or 160 BID

Active Comparator: valsartan
Participants will be randomized to two treatment arms in a 1:1, double blinded fashion. In this arm, Valsartan 80 mg and 160 mg will be used as comparative drug, taken orally BID at home. Depending on the screening/run-in dose the subjects in this arm will get either valsartan 80 mg BID or valsartan 160 mg BID. During the treatment period the dose of valsartan will be up-titrated to the highest tolerated dose (160 mg BID) or maintained at 80 mg BID if up-titration is not possible. Dose modifications are allowed until week 4 after the randomization. In order to be eligible for the final assessments, the subject has to tolerate at least 80 mg BID dose of valsartan. The treatment phase will be a minimum of 8 weeks, and a maximum of 10 weeks.
Drug: valsartan
Valsartan 80 or 160 mg BID

Drug: placebo to sacubitril/valsartan
placebo to sacubitril/valsartan 100 or 200 mg BID




Primary Outcome Measures :
  1. Change from baseline in cardiac oxygen consumption and efficiency of cardiac work [ Time Frame: baseline, at week 6 ]
    Change from baseline in cardiac oxygen consumption and efficiency of cardiac work after 6 weeks of stable sacubitril/valsartan therapy compared to that of in patients on valsartan therapy using 11C-acetate positron emission tomography (PET).



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 40-80 years of age
  • Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.
  • Systolic BP 110-160 mm Hg
  • Optimal standard HF therapy according to European Society of Cardiology (ESC) guidelines at a stable dose for at least 4 weeks before the screening visit.

Exclusion criteria:

  • Estimated glomerular filtration rate (eGFR) < 45 ml/min
  • Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300427


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Finland
Novartis Investigative Site Recruiting
Turku, Finland
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03300427    
Other Study ID Numbers: CLCZ696BFI03
2017-002113-64 ( EudraCT Number )
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Heart failure with reduced left ventricular ejection fraction
LVEF
Cardiac dysfunction
Heart muscle dysfunction
Left ventricular (LV) dilation
Left ventricular hypertrophy
HF
AHF
CHF
CCF
acute heart failure
chronic heart failure
congestive heart failure
congestive cardiac failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action