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Status unknownNCT02779660RIPPAFUpdated Aug 22, 2017

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

An interventional study of Remote ischemic preconditioning (RIPC) and sham-intervention in Atrial Fibrillation, sponsored by Jedrzej Kosiuk. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Jedrzej Kosiuk · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 146 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Jedrzej Kosiuk as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • planned invasive Atrial Fibrillation ablation

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Remote ischemic preconditioning (RIPC)

  • Placebo comparator
    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.

    Procedure: sham-intervention

Interventions

  • ProcedureRemote 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.

  • Proceduresham-intervention

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

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What researchers measure

Primary outcomes

  1. inducibility of Atrial Fibrillation by high-rate pacing of 20 s

    Time frame: during the Atrial Fibrillation Ablation procedure

  2. sustainability of Atrial Fibrillation measured in seconds

    Time frame: during the Atrial Fibrillation Ablation procedure

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 31356986 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02779660
Lead sponsor
Jedrzej Kosiuk
Responsible party
Jedrzej Kosiuk (MD Jedrzej Kosiuk, Heart Center Leipzig - University Hospital) — Sponsor-investigator
First posted
May 20, 2016
Start date
May 2016
Primary completion
May 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Aug 22, 2017

Study contacts

Jedrzej Kosiuk, MD
Contact
Jedrzej.Kosiuk@helios-kliniken.de

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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