UMIN-CTR Clinical Trial

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

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Basic information

Public 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

Acronym

SAVASAVA Study

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

Scientific Title:Acronym

SAVASAVA Study

Region

Japan


Condition

Condition

Patients with heart failure who finished the PARALLEL-HF trial

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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.

Key secondary outcomes

The second endpoint was the change in echocardiographic parameters related to myocardial remodeling from the baseline to week 24.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with chronic HF in our hospital participated in the PARALLEL-HF trial

Key exclusion criteria

Patients who did not consent to participate

Target sample size

11


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Nakamura

Organization

Iwate Prefectural Central Hospital

Division name

Department of Cardiology

Zip code

020-0066

Address

1-4-1, Ueda, Morioka, Iwate

TEL

019-653-1151

Email

Akihironakamura0223@msn.com


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Nakamura

Organization

Iwate Prefectural Central Hospital

Division name

Department of Cardiology

Zip code

020-0066

Address

1-4-1, Ueda, Morioka, Iwate

TEL

019-653-1151

Homepage URL


Email

Akihironakamura0223@msn.com


Sponsor or person

Institute

Department of Cardiology, Iwate Prefectural Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Iwate Prefectural Central Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iwate Prefectural Central Hospital

Address

1-4-4, Ueda, Morioka, Iwate

Tel

019-653-1151

Email

yoshiko-tanaka@pref.iwate.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 08 Month 05 Day


Related information

URL releasing protocol

http://chuo-hp.jp/oshirase/chikentop/

Publication of results

Unpublished


Result

URL related to results and publications

http://chuo-hp.jp/oshirase/chikentop/

Number of participants that the trial has enrolled

11

Results

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).

Results date posted

2022 Year 08 Month 05 Day

Results Delayed

Delay expected

Results Delay Reason

No accept for any journals

Date of the first journal publication of results

2022 Year 12 Month 01 Day

Baseline Characteristics

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.

Participant flow

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).

Adverse events

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.

Outcome measures

Switching from ARNI to ARB may worsen HF due to returning to myocardial remodeling induced by a sustained decline in ANP levels.

Plan to share IPD

None

IPD sharing Plan description

None


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 12 Month 01 Day

Date of IRB

2020 Year 12 Month 03 Day

Anticipated trial start date

2021 Year 01 Month 05 Day

Last follow-up date

2021 Year 07 Month 30 Day

Date of closure to data entry

2021 Year 08 Month 31 Day

Date trial data considered complete

2021 Year 09 Month 01 Day

Date analysis concluded

2022 Year 10 Month 01 Day


Other

Other related information

The follow-up visits were conducted at 4, 12, and 24 weeks


Management information

Registered date

2022 Year 08 Month 05 Day

Last modified on

2022 Year 08 Month 05 Day



Link to view the page

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