UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043293 |
|---|---|
| Receipt number | R000049430 |
| Scientific Title | Effect of PHARMacological treatment in hospitalized patients with Heart Failure |
| Date of disclosure of the study information | 2021/02/12 |
| Last modified on | 2026/08/16 23:39:50 |
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Basic information
Public title
Effect of PHARMacological treatment in hospitalized patients with Heart Failure
Acronym
PHARM-HF
Scientific Title
Effect of PHARMacological treatment in hospitalized patients with Heart Failure
Scientific Title:Acronym
PHARM-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ascertain the cardiovascular agonists used, blood pressure, and renal function of patients admitted for exacerbation of heart failure during the first 10 days of hospitalization (consecutive days), at discharge, and at the first outpatient visit. In addition, changes in blood pressure and renal function and subjective symptoms, cardiac function, biomarkers, and activity level will be ascertained.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic and diastolic blood pressure during hospitalization
Key secondary outcomes
Clinical outcome (death and rehospitalization due to heart failure) on 1 and 2 years after discharge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients with a diagnosis of worsening heart failure defined by the Framingham criteria.
Key exclusion criteria
Use of mechanical circulatory support, mechanical ventilation, hemodialysis, and inotropes(dobutamine, noradrenaline, dopamine, epinephrine).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University Hospital
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
m_koni@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
Homepage URL
m_koni@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura, Kanazawa-ku
Tel
0457872800
ycu_crb@yokohama-cu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000049430
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41440-025-02501-8
Number of participants that the trial has enrolled
256
Results
Herein we showed a downward trend in BP following ARNI initiation in decompensated HF. Early changes in BP after ARNI initiation were comparable with those in the ACEi/ARB group.
Results date posted
| 2026 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of the 256 patients enrolled in the present study was 77.7 +- 13.3 years, with 53.9% being male, and the LVEF was 40 +- 17%.
Participant flow
BP was measured in a seated position at rest and on the same arm at each time point. Except at the time of admission, BP was measured before breakfast, and values were recorded for 10 days from the day of admission. Blood samples were collected on admission, on days 6-8, before discharge, and at the first outpatient visit. Left ventricular ejection fraction (LVEF) and the presence or absence of valvular heart disease within the past 6 months (including current hospitalization) were assessed using echocardiography. Smoking status, medical history, and current medications were documented during hospitalization, and all medications were recorded for 10 days from the date of admission, at discharge, and the first outpatient visit.
Adverse events
Within the first 10 days of hospitalization, 7 (6.1%) and 2 (3.8%) patients in ARNI and ACEi/ARB groups discontinued each drug, respectively. Of these, 4 patients in the ARNI group recorded a systolic BP below 100 mmHg before discontinuation. None of the patients in the ACEi/ARB group had a systolic BP below 100 mmHg. There were no cases of eGFR decrease by 30% or more or hyperkalemia (K > 5.5 mEq/L) before discontinuation.
Outcome measures
Three days after the initiation of each drug, systolic BP dropped from 132 +- 24 to 117 +- 19 mmHg (ARNI group, p < 0.001) and 131 +- 19 to 117 +- 21 mmHg (ACEi/ARB group, p < 0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No longer recruiting
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049430
