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Am Heart J. 2008 Oct;156(4):641-648.e1. doi: 10.1016/j.ahj.2008.05.019.

A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

Collaborators (158)

Mattioni T, Swarup V, Scrivano S, Williams C, Niazi I, Phan N, Dahme R, Kiemen JA, Cohen AI, Polizzi SM, Bickett K, Merliss A, Krueger SK, Christy J, Hao SC, Hongo RH, Bernier EJ, Im G, Jones G, Rao A, Dicken T, Gang ES, Karlsberg RP, Thottam MM, Gerez TS, Greenberg SM, Seeman R, Nedda E, Shih HT, Pourciau C, Akhtar M, Chambers A, Corbisiero R, Dewey L, Langberg J, Smith A, Heeke S, Steinberg J, Smull D, Mitchell M, Dickson J, Lieberman RA, Mick AB, Buser GA, Wellford AL 4th, Whitney EL, Farris SW, Czerska B, Leszczynski K, Wish M, Friehling T, Wolfe J, Blake M, John RM, Martin DT, Hook BG, Byrne JM, Worley SJ, Gohn DC, Noll D, Neelagaru SB, Welch T, Hayes DL, Rea RF, Trusty J, Hagen ML, Costanzo MR, Elder L, Klein S, Bensimhon D, Chase P, Lamas GA, Florin TJ, Restrepo BE, Baran DA, Adams L, Goldberger J, Galvez D, Small K, Kalman J, Surach C, Abi-Samra F, Donahue T, Lunn M, Hardy C, Love CC, Binkley PE, Haas GJ, Sanuk L, Yamokoski L, Heywood J, Payne A, Nademanee K, Drew C, Volosin K, Riggs J, Murphy AL, Oehmann VM, Lau SK, Cheng N, Yiu P, Goldberg HR, Shumaker V, McGrew F 3rd, Hamilton B, Raval N, Chronos N, Prater SP, Conley S, Steinberg JS, Kukin ML, Knox R, Varley CB, Bank A, Adler S, Underwood RD, Tindell L, Gallinghouse GJ, Cardinal DS, Scallon CM, Weiner S, Holt L, Tallaj J, McElderry T Jr, Rohrer K, Herweg B, Aydelott-Nuce R, Yarborough MA, Joglar J, Obel O, Nguyen C, Red D, Sweitzer N, Wathen M, Darber D, McDonough NM, Dye LD, Wood M, Ellenbogen K, Hess M, Hall K, Abraham WT, Kadish A, Nademanee K, Carson P, Bourge R, Ellenbogen KA, Parides M, O'Conner C, Anand I, Goldstein S, Gottlieb S, Natale A, Naftel D, Callans D, Goldsmith R, DiTullio M, Schulman SP.

Author information

1
The Ohio State University Heart Center, Division of Cardiovascular Medicine, Columbus, OH 43210-1252, USA. william.abraham@osumc.edu

Abstract

Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00112125.

PMID:
18926146
DOI:
10.1016/j.ahj.2008.05.019
[Indexed for MEDLINE]
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