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

NCT ID: NCT02779660

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RIPC-Group

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.

Group Type EXPERIMENTAL

Remote ischemic preconditioning (RIPC)

Intervention Type PROCEDURE

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.

Control-Group

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.

Group Type PLACEBO_COMPARATOR

sham-intervention

Intervention Type PROCEDURE

In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals

Interventions

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Remote ischemic preconditioning (RIPC)

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

sham-intervention

In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jedrzej Kosiuk

OTHER

Sponsor Role lead

Responsible Party

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Jedrzej Kosiuk

MD Jedrzej Kosiuk

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Herzzentrum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jedrzej Kosiuk, MD

Role: CONTACT

Facility Contacts

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Jedrzej Kosiuk

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31356986 (View on PubMed)

Other Identifiers

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RIPPAF V1

Identifier Type: -

Identifier Source: org_study_id

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