NCT02258061

Brief Summary

The optimal pacing rate during cardiac resynchronization therapy (CRT) is not known. Investigators investigate the impact of changing basal pacing frequencies on autonomic nerve function, cardiopulmonary exercise capacity and self-perceived quality of life (QoL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

September 29, 2014

Last Update Submit

October 6, 2014

Conditions

Cardiac Resynchronization TherapyHeart FailureBi-ventricular PacingSympathetic ActivityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • N-terminal pro-brain natriuretic peptide

    Observing the change in N-terminal pro-brain natriuretic peptide in 15 patients

    3 months

Secondary Outcomes (3)

  • Autonomic nerve function

    3 months

  • Peak oxygen consumption (pVO2)

    3 months

  • Self-perceived quality of life

    3 months

Study Arms (2)

DDD-80 pacing

EXPERIMENTAL

To investigate the impact of basal pacing rates of 80-bpm (DDD-80) in CRT patients on: (i) autonomic nerve function; assessed by micro-neurography, and N-terminal pro-brain natriuretic peptide (NT-proBNP) and (ii) peak oxygen consumption (pVO2) and (iii) self-perceived quality of life (QoL).

Procedure: DDD-80

DDD-60 pacing

SHAM COMPARATOR

To investigate the impact of basal pacing rates of 60-bpm (DDD-60) in CRT patients on: (i) autonomic nerve function; assessed by micro-neurography, and N-terminal pro-brain natriuretic peptide (NT-proBNP) and (ii) peak oxygen consumption (pVO2) self-perceived quality of life (QoL).

Procedure: DDD-60

Interventions

DDD-80PROCEDURE

Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study.

DDD-80 pacing
DDD-60PROCEDURE

Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study.

DDD-60 pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis with idiopathic dilated cardiomyopathy
  • New York Heart Association functional (NYHA) class II-IV
  • Sinus rhythm,
  • Hemodynamically stable
  • Biventricular pacing \> 90% of the time
  • On optimal medical treatment for heart failure with no changes in medications during the past 3 months.

You may not qualify if:

  • NYHA I
  • unable to perform exercise test (e.g. chronic obstructive pulmonary disease, severe arthritis)
  • cancer
  • plasma creatinine \> 200 micromole per litre
  • an admission for decompensated HF or acute coronary syndrome in the preceding 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, University hospital of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (7)

  • Kuniyoshi RR, Martinelli M, Negrao CE, Siqueira SF, Rondon MU, Trombetta IC, Kuniyoshi FH, Laterza MC, Nishioka SA, Costa R, Tamaki WT, Crevelari ES, Peixoto Gde L, Ramires JA, Kalil R. Effects of cardiac resynchronization therapy on muscle sympathetic nerve activity. Pacing Clin Electrophysiol. 2014 Jan;37(1):11-8. doi: 10.1111/pace.12254. Epub 2013 Aug 16.

    PMID: 23952584BACKGROUND

  • Agostoni P, Corra U, Cattadori G, Veglia F, Battaia E, La Gioia R, Scardovi AB, Emdin M, Metra M, Sinagra G, Limongelli G, Raimondo R, Re F, Guazzi M, Belardinelli R, Parati G, Magri D, Fiorentini C, Cicoira M, Salvioni E, Giovannardi M, Mezzani A, Scrutinio D, Di Lenarda A, Mantegazza V, Ricci R, Apostolo A, Iorio A, Paolillo S, Palermo P, Contini M, Vassanelli C, Passino C, Piepoli MF; MECKI Score Research Group. Prognostic value of indeterminable anaerobic threshold in heart failure. Circ Heart Fail. 2013 Sep 1;6(5):977-87. doi: 10.1161/CIRCHEARTFAILURE.113.000471. Epub 2013 Jul 23.

    PMID: 23881847BACKGROUND

  • Stockburger M, de Teresa E, Lamas G, Desaga M, Koenig C, Habedank D, Cobo E, Navarro X, Wiegand U. Exercise capacity and N-terminal pro-brain natriuretic peptide levels with biventricular vs. right ventricular pacing for atrioventricular block: results from the PREVENT-HF German Substudy. Europace. 2014 Jan;16(1):63-70. doi: 10.1093/europace/eut217. Epub 2013 Jul 16.

    PMID: 23861381BACKGROUND

  • Brenyo A, Barsheshet A, Rao M, Huang DT, Zareba W, McNitt S, Hall WJ, Peterson DR, Solomon SD, Moss AJ, Goldenberg I. Brain natriuretic peptide and cardiac resynchronization therapy in patients with mildly symptomatic heart failure. Circ Heart Fail. 2013 Sep 1;6(5):998-1004. doi: 10.1161/CIRCHEARTFAILURE.112.000174. Epub 2013 Jun 25.

    PMID: 23801020BACKGROUND

  • Shukla A, Curtis AB, Mehra MR, Albert NM, Gheorghiade M, Heywood JT, Liu Y, O'Connor CM, Reynolds D, Walsh MN, Yancy CW, Fonarow GC. Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF. Pacing Clin Electrophysiol. 2013 Apr;36(4):433-43. doi: 10.1111/pace.12090. Epub 2013 Feb 4.

    PMID: 23380000BACKGROUND

  • Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, Weiner S, Kraus SM, Stolen KQ, Gold MR. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25.

    PMID: 22830441BACKGROUND

  • Ghotbi AA, Sander M, Kober L, Philbert BT, Gustafsson F, Hagemann C, Kjaer A, Jacobsen PK. Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-Ischemic Heart Failure Patients: A Randomized Crossover Pilot Trial. PLoS One. 2015 Sep 18;10(9):e0138124. doi: 10.1371/journal.pone.0138124. eCollection 2015.

    PMID: 26382243DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Adam A Ghotbi, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 7, 2014

Study Start

August 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

DK(1)