Optimal Cardiac Resynchronization Therapy Pacing Rate

Heart Failure Clinical Trial

Official title:

Optimal Cardiac Resynchronization Therapy Pacing Rate in Non-ischemic Heart Failure Patients: a Randomized Crossover Pilot Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258061
• Other study ID #: H-3-2011-034
• Status: Completed
• Phase: Phase 0
• First received: September 29, 2014
• Last updated: October 6, 2014
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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).

Description:

This is a double-blinded randomized crossover pilot study testing two basal pacing rates:

DDD-60 versus DDD-80. Each patient is paced for 2 periods of 90 days with DDD-60 and DDD-80 in a randomly sequence.

Blood samples NT-proBNP plasma levels are analysed at baseline and at the end of each phase using electrochemiluminescence-immunoassay. Patients rest for 15 minutes before the samples are taken.

These result are monitored by supervisory group to ensure that increase of more than 15% than baseline values result in termination of study.

Investigators conduct two distinct questionnaires (Minnesota Living with Heart Failure (LIfHE) questionnaire and Medical Outcome Survey Short Form (SF-36)) A symptom limiting bicycle (Ergoline, Baden-Württemberg, Germany) exercise test is performed to measure maximum work capacity and oxygen consumption at each phase.

Recordings of resting muscle sympathetic nerve activity (MSNA) are sought in all patients at both rates of pacing. All patients are studied on the same set-up in the semi-recumbent position after 30 minutes of rest. Tungsten microelectrodes (Iowa Bioengineering) are inserted into the common peroneal nerve just below the knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis with idiopathic dilated cardiomyopathy

• CRT device implanted (with initial indication in accordance with European guidelines) at least 6 months prior to inclusion.

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bi-ventricular Pacing
• Cardiac Resynchronization Therapy
• Heart Failure
• Quality of Life
• Sympathetic Activity

Intervention

Procedure:
• DDD-80
Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study.
• DDD-60
Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study.

Locations

Country	Name	City	State
Denmark	Rigshospitalet, University hospital of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Agostoni P, Corrà 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, Magrì 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. — View Citation

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. — View Citation

Kuniyoshi RR, Martinelli M, Negrão 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-terminal pro-brain natriuretic peptide	Observing the change in N-terminal pro-brain natriuretic peptide in 15 patients	3 months	Yes
Secondary	Autonomic nerve function	Autonomic nerve function by micro-neurography measured in bursts/min and bursts/cardiac cycle in 15 patients	3 months	Yes
Secondary	Peak oxygen consumption (pVO2)	pVO2 measured by a symptom limiting bicycle exercise test in 15 patients	3 months	Yes
Secondary	Self-perceived quality of life	Measured with the LIfHE and SF-36 questionnaires in 15 patients	3 months	Yes