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Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study (RIPPAF)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic preconditioning (RIPC)
sham-intervention
Sponsored by
Jedrzej Kosiuk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • planned invasive Atrial Fibrillation ablation

Exclusion Criteria:

  • AF in ECG at Admission
  • history of AF ablation
  • age <18
  • pregnancy
  • neoplastic disorders
  • acute or systemic inflammation, autoimmune diseases
  • documented atrial flutter

Sites / Locations

  • Herzzentrum LeipzigRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RIPC-Group

Control-Group

Arm Description

After randomization patients will undergo 3 sessions of RIPC (Remote ischemic preconditioning) intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.

After randomization patients will undergo 3 sessions of sham-intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.

Outcomes

Primary Outcome Measures

inducibility of Atrial Fibrillation by high-rate pacing of 20 s
sustainability of Atrial Fibrillation measured in seconds

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
August 17, 2017
Sponsor
Jedrzej Kosiuk
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1. Study Identification

Unique Protocol Identification Number
NCT02779660
Brief Title
Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
Acronym
RIPPAF
Official Title
Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jedrzej Kosiuk

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results. The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk. Interim Analysis will be done after 73 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC-Group
Arm Type
Experimental
Arm Description
After randomization patients will undergo 3 sessions of RIPC (Remote ischemic preconditioning) intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.
Arm Title
Control-Group
Arm Type
Placebo Comparator
Arm Description
After randomization patients will undergo 3 sessions of sham-intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning (RIPC)
Intervention Description
RIPC will be induced by the application of 3 short episodes (5 minutes) of forearm ischemia by cuff sphygmomanometer inflation separated by 5 minutes of reperfusion.
Intervention Type
Procedure
Intervention Name(s)
sham-intervention
Intervention Description
In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals
Primary Outcome Measure Information:
Title
inducibility of Atrial Fibrillation by high-rate pacing of 20 s
Time Frame
during the Atrial Fibrillation Ablation procedure
Title
sustainability of Atrial Fibrillation measured in seconds
Time Frame
during the Atrial Fibrillation Ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: planned invasive Atrial Fibrillation ablation Exclusion Criteria: AF in ECG at Admission history of AF ablation age <18 pregnancy neoplastic disorders acute or systemic inflammation, autoimmune diseases documented atrial flutter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jedrzej Kosiuk, MD
Email
Jedrzej.Kosiuk@helios-kliniken.de
Facility Information:
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jedrzej Kosiuk
Email
Jedrzej.Kosiuk@helios-kliniken.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31356986
Citation
Kosiuk J, Langenhan K, Stegmann C, Uhe T, Dagres N, Dinov B, Kircher S, Richter S, Sommer P, Bertagnolli L, Bollmann A, Hindricks G. Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial. Heart Rhythm. 2020 Jan;17(1):3-9. doi: 10.1016/j.hrthm.2019.07.026. Epub 2019 Jul 26.
Results Reference
derived

Learn more about this trial

Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

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