UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042364 |
|---|---|
| Receipt number | R000048194 |
| Scientific Title | Prospective oBsErvatioNal study of the EFfect of catheter ablatIon among patienTs with Heart Failure with Preserved Ejection Fraction and persistent atrial fibrillation |
| Date of disclosure of the study information | 2020/11/07 |
| Last modified on | 2023/05/09 17:45:09 |
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Basic information
Public title
Prospective oBsErvatioNal study of the EFfect of catheter ablatIon among patienTs with Heart Failure with Preserved Ejection Fraction and persistent atrial fibrillation
Acronym
BENEFIT-HFpEF
Scientific Title
Prospective oBsErvatioNal study of the EFfect of catheter ablatIon among patienTs with Heart Failure with Preserved Ejection Fraction and persistent atrial fibrillation
Scientific Title:Acronym
BENEFIT-HFpEF
Region
| Japan |
Condition
Condition
Patients with heart failure with preserved ejection fraction and persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of catheter ablation on exercise capacity among patients with heart failure with preserved ejection fraction and persistent atrial fibrillation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in peak oxygen uptake between before and 6 months of ablation
Key secondary outcomes
Improvement of QOL, change of CPX parameters other than peakVO2, change of NT-proBNP value, change of echocardiography parameters, number of hospitalizations for heart failure, mortality rate, recurrence rate of atrial fibrillation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. New York Heart Association functional class (NYHA) classification II-IV
B. Left ventricular ejection fraction (LVEF) is 45% or more
C. Structural heart disease (left ventricular hypertrophy, left atrial enlargement) or diastolic dysfunction
D. Satisfy 1 or 2
1. Patients who have been hospitalized for heart failure or are using diuretics: NT-proBNP> 600 pg / mL
2. NT-proBNP> 900pg / mL
Key exclusion criteria
A. Left atrium diameter> 60mm
B. Contraindications for anticoagulant therapy or heparin
C. History of ablation to previous AF
D. Acute coronary syndrome, emergency coronary artery reconstruction, heart surgery, major vascular surgery, TIA, stroke within the last 3 months
E. Coronary artery reconstruction within 1 last month
F. Acute heart failure requiring treatment with diuretics, vasodilators, inotropes, etc. within 1 month (including additional outpatient treatment)
G. Plan for coronary artery reconstruction, heart surgery, and major vascular surgery within the next 3 months
H. Listed for heart transplantation, after heart transplantation, or wearing left ventricular assisted circulation
I. Severe valvular disease that may be indicated for surgery
J. Untreated or inadequate conditions that can affect the course of heart failure
Systolic blood pressure 180 mmHg or more
Heart rate 110 bpm or more
K. Untreated hyperthyroidism or hypothyroidism
L. Findings suspected that other diseases cause symptoms of fatigue and dyspnea
Severe chronic obstructive pulmonary disease (home oxygen therapy, hospitalization within 12 months, oral steroids)
Pulmonary arterial hypertension
Hemoglobin <10g / dL
Body mass index> 40kg / m2
M. Patients with renal dysfunction or dialysis with estimated glemerular filtration rate <30 mL / min / 1.73 m2
N. Liver disease: AST or ALT is more than 3 times the standard value, or T-Bil 1.5 mg / dL or more
O. Coexistence of orthopedic problems and neuromuscular diseases that are difficult to perform cardiopulmonary exercise test
P. Some diseases with a predicted life prognosis of less than 3 years
Q. There is a possibility that the condition may occur during pregnancy, lactation, or during a research institute.
R. Medical medical conditions that may interrupt research or reduce credibility
S. When other clinical studies using drugs / devices make it impossible to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442147
murohara@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kondo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442147
Homepage URL
toru.k0927@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Department of Cardiology
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
Nagoya University Graduate School of Medicine, Department of Cardiology
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442147
toru.k0927@med.nagoya-u.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
| 2020 | Year | 11 | Month | 07 | 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
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
| 2020 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients' demographics, laboratory data, electrocardiogram, echocardiography, cardiopulmonary exercise testing, QOL, catheter ablation data, prognostic data.
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048194
