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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name