Unique ID issued by UMIN | UMIN000048602 |
---|---|
Receipt number | R000055376 |
Scientific Title | Effects of switching from sacubitril/valsartan to valsartan alone on plasma levels of natriuretic peptides and cardiac remodeling in heart failure with reduced ejection fraction |
Date of disclosure of the study information | 2022/08/05 |
Last modified on | 2022/08/05 14:56:57 |
Effects of switching from sacubitril/valsartan to valsartan alone on plasma levels of natriuretic peptides and cardiac remodeling in heart failure with reduced ejection fraction
SAVASAVA Study
Effects of switching from sacubitril/valsartan to valsartan alone on plasma levels of natriuretic peptides and cardiac remodeling in heart failure with reduced ejection fraction
SAVASAVA Study
Japan |
Patients with heart failure who finished the PARALLEL-HF trial
Cardiology | Adult |
Others
NO
To examine the impact of switching from angiotensin receptor-neprilysin inhibitor (ARNI) to angiotensin-receptor blocker (ARB) on plasma levels of natriuretic peptides and myocardial remodeling.
Safety
The primary endpoint was percent change (%Change) from baseline to week 24 in plasma A-, B-, and N-terminal pro-B-type natriuretic peptide (ANP, BNP, and NT-proBNP) levels.
The second endpoint was the change in echocardiographic parameters related to myocardial remodeling from the baseline to week 24.
Observational
20 | years-old | < |
80 | years-old | >= |
Male and Female
patients with chronic HF in our hospital participated in the PARALLEL-HF trial
Patients who did not consent to participate
11
1st name | Akihiro |
Middle name | |
Last name | Nakamura |
Iwate Prefectural Central Hospital
Department of Cardiology
020-0066
1-4-1, Ueda, Morioka, Iwate
019-653-1151
Akihironakamura0223@msn.com
1st name | Akihiro |
Middle name | |
Last name | Nakamura |
Iwate Prefectural Central Hospital
Department of Cardiology
020-0066
1-4-1, Ueda, Morioka, Iwate
019-653-1151
Akihironakamura0223@msn.com
Department of Cardiology, Iwate Prefectural Central Hospital
Iwate Prefectural Central Hospital
Local Government
Iwate Prefectural Central Hospital
1-4-4, Ueda, Morioka, Iwate
019-653-1151
yoshiko-tanaka@pref.iwate.jp
NO
2022 | Year | 08 | Month | 05 | Day |
http://chuo-hp.jp/oshirase/chikentop/
Unpublished
http://chuo-hp.jp/oshirase/chikentop/
11
The %Change in ANP and NT-proBNP levels was significantly greater in the ARB-switch group than that in the ARNI-continue group,
wheras that in BNP levels was not significantly different between the ARNI-continue and ARB-switch group.
In the ARB-switch group, there was a
significant increase from the baseline to week 24 in left ventricular (LV) end-systolic volume (p = 0.043) and LV peak-systolic wall stress (p = 0.012), and a trend toward a decrease in LV ejection fraction (p = 0.080).
2022 | Year | 08 | Month | 05 | Day |
Delay expected |
No accept for any journals
2022 | Year | 12 | Month | 01 | Day |
The patient age of the ARB-switch group was significantly smaller than that of the ARNI-continue group (p = 0.028). No significant differences in sex, body mass index, body surface area, heart rate, BP, risk factors, biochemical data, and medications were not found between the two groups.
Despite the recommendation to continue the ARNI treatment, six of 11 patients desired the change from the treatment with ARNI to that with ARB because of medical costs or two weeks visit after the study. The remaining five patients wanted to continue the treatment with ARNI. After completed the core study between December 2020 and January 2021, two groups were enrolled in this study: five patients who requested the continuous treatment with ARNI: sacubitril valsartan of 400 mg/day (ARNI continue group);and six patients who requested the treatment with ARB: valsartan of 160 mg/day (ARB switch group).
In all patients, the ARNI or ARB treatment was not changed or discontinued during the study period. No patients were given additional medications for HF such as sodium-glucose cotransporter-2 inhibitors. Unplanned hospitalization due to worsening HF or other cardiovascular events was not observed in the both groups.
Switching from ARNI to ARB may worsen HF due to returning to myocardial remodeling induced by a sustained decline in ANP levels.
None
None
Completed
2020 | Year | 12 | Month | 01 | Day |
2020 | Year | 12 | Month | 03 | Day |
2021 | Year | 01 | Month | 05 | Day |
2021 | Year | 07 | Month | 30 | Day |
2021 | Year | 08 | Month | 31 | Day |
2021 | Year | 09 | Month | 01 | Day |
2022 | Year | 10 | Month | 01 | Day |
The follow-up visits were conducted at 4, 12, and 24 weeks
2022 | Year | 08 | Month | 05 | Day |
2022 | Year | 08 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055376
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |