UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045229 |
|---|---|
| Receipt number | R000051667 |
| Scientific Title | Effect of Long-Acting vs. Short-Acting Loop Diuretics and Neurohormonal Agents on Patients' Quality-of-Life Among Patients with Heart Failure |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2024/02/24 10:55:31 |
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Basic information
Public title
Effect of Long-Acting vs. Short-Acting Loop Diuretics and Neurohormonal Agents on Patients' Quality-of-Life Among Patients with Heart Failure
Acronym
LAQUA-HF Trial
Scientific Title
Effect of Long-Acting vs. Short-Acting Loop Diuretics and Neurohormonal Agents on Patients' Quality-of-Life Among Patients with Heart Failure
Scientific Title:Acronym
LAQUA-HF Trial
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
LAQUA-HF is a pragmatic, randomized, with a 2x2 factorial design to compare 1) torsemide versus furosemide and 2) angiotensin receptor II blocker/neprilysin inhibitor (sacubitril/valsartan) versus sodium-glucose cotransporter 2 inhibitors (dapagliflozin 10 mg); the primary objective is to compare the patients' reported outcomes over 6 months after randomization in patients with heart failure with reduced ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The mean changes in Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score from the start of the intervention to 6 months.
Key secondary outcomes
- The hierarchical composite endpoint consisting of the time to all-cause death, total number of worsening HFEs, the time to first HFEs within 6 months, and non-improvement in KCCQ-OSS of less than 5 points from baseline to 6 months, assessed by the win ratio.
- The composite of all-cause death and the non-improvement in KCCQ-OS score (less than 5 points) from the start of the intervention to 6 months.
The mean changes in the NT-proBNP levels from baseline to 6 months.
- The composite of all-cause death and non-improvement in the NT-proBNP levels (less than 20%) from the start of the intervention to 6 months.
- The composite of all-cause death, heart failure hospitalization, non-improvement in KCCQ-OS score (less than 5 points), and non-improvement in the NT-proBNP levels (less than 20%) from the start of the intervention to 6 months.
- The incidence of all-cause death, cardiovascular death, heart failure hospitalization, unscheduled office visits for worsening heart failure with an increasing dose of diuretics or intravenous infusion from the start of the intervention to 6 months.
- The mean changes in the KCCQ-clinical summary (KCCQ-CS) score and non-improvement in the KCCQ-CS score (less than 5 points) from the start of the intervention to 6 months.
- The mean changes in the KCCQ- total symptom score (KCCQ-TS) and non-improvement in the KCCQ-TS score (less than 5 points) from the start of the intervention to 6 months.
- The mean changes in left ventricular ejection fraction (LVEF) from the start of the intervention to 6 months.
- The mean changes in estimated glomerular filtration ratio (eGFR) from the start of the intervention to 6 months.
- The incidence of all-cause death, cardiovascular death, and heart failure hospitalization from the start of the intervention to 2 years.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Torsemide (oral dosing of torsemide compared to furosemide will be 1mg: 2.5-5mg) with sacubitril/valsartan 50 mg b.i.d. as started dose, after every 2-4 weeks dose will be up titrated to the goal of 200 mg b.i.d
Other heart failure medications (except for an ACE inhibitor or ARB) will be continued during the trial.
Interventions/Control_2
Furosemide with sacubitril/valsartan 50 mg b.i.d. as started dose, after every 2-4 weeks dose will be up titrated to the goal of 200 mg b.i.d.
Other heart failure medications (except for an ACE inhibitor or ARB) will be continued during the trial.
Interventions/Control_3
Torsemide (oral dosing of torsemide compared to furosemide will be 1mg: 2.5-5.0mg) with dapagliflozin 10mg once a day.
Other heart failure medications (except for a sacubitril/valsartan) will be continued during the trial.
Interventions/Control_4
Furosemide with dapagliflozin 10mg once a day.
Other heart failure medications (except for a sacubitril/valsartan) will be continued during the trial.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic heart failure with/without hospitalization within 1 year before enrollment
A. Patients hospitalized with worsening of chronic heart failure, or new diagnosis of heart failure within 1 year before enrollment AND has an elevated natriuretic peptide level (either NT-proBNP greater than or equal to 300 pg/mL or BNP greater than or equal to 100 pg/mL) with the most recent value used to determine eligibility. (In patients with atrial fibrillation, the level of NT-proBNP will be greater than or equal to 450 pg/mL or BNP greater than or equal to 150 pg/mL)
B. Patients with chronic heart failure without hospitalization within 1 year before enrollment AND have an elevated natriuretic peptide level (either NT-proBNP greater than or equal to 600 pg/mL or BNP greater than or equal to 150 pg/mL) with the most recent value used to determine eligibility. (In patients with atrial fibrillation, the level of NT-proBNP will be greater than or equal to 900 pg/mL or BNP greater than or equal to 225 pg/mL)
2) Patients with heart failure (NYHA functional class II, III, or IV) receiving oral loop diuretic.
3) Patients whose left ventricular ejection fraction is less than or equal to 50% within 1 year before enrollment.
4) Above 20 years of age
5) Able to consent for the trial.
Key exclusion criteria
1) Symptomatic hypotension and/or a systolic blood pressure < 100 mmHg at screening
2) Serum potassium greater than or equal to5.4 mEq/L at screening
3) eGFR < 30 ml/min/1.73m or end-stage renal disease requiring renal replacement therapy at the time of screening
4) Pregnant or nursing women, or history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, as well as known or suspected contraindications to the study drugs.
5) Inability or unwillingness to comply with the study requirements
6) Patients who are unable to obtain written consent or require a substitute.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Kohsaka |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6702
sk@keio.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Ikemura |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6702
Homepage URL
ikemu0129@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, School of medicine, Independent Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.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
慶應義塾大学病院（東京都）
榊原記念病院（東京都）
防衛医科大学校病院（埼玉県）
東京都済生会中央病院（東京都）
済生会宇都宮病院（栃木県）
埼玉医科大学国際医療センター（埼玉県）
杏林大学医学部付属病院（東京都）
東京慈恵会医科大学附属病院（東京都）
独立行政法人 国立病院機構 埼玉病院（埼玉県）
独立行政法人 国立病院機構 東京医療センター（東京都）
浜松医科大学医学部附属病院（静岡県）
足利赤十字病院（栃木県）
川崎市立川崎病院（神奈川県）
国際医療福祉大学成田病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
240
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051667
