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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: sacubitril/valsatran Drug: valsartan Drug: placebo to valsartan Drug: placebo to sacubitril/valsartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
Valsartan 80 or 160 mg BID
Drug: placebo to sacubitril/valsartan
placebo to sacubitril/valsartan 100 or 200 mg BID
- 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).
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
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|
|Novartis Investigative Site||Recruiting|