Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

NCT ID: NCT00001530

Last Updated: 2008-03-04

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-04-30

Study Completion Date

2000-05-31

Brief Summary

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DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following \>4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had \>50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

Detailed Description

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DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following \>4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had \>50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

Conditions

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Cardiomyopathy, Hypertrophic

Eligibility Criteria

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Exclusion Criteria

Females must have a negative pregnancy test.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Locations

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National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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McDonald K, McWilliams E, O'Keeffe B, Maurer B. Functional assessment of patients treated with permanent dual chamber pacing as a primary treatment for hypertrophic cardiomyopathy. Eur Heart J. 1988 Aug;9(8):893-8. doi: 10.1093/oxfordjournals.eurheartj.a062584.

Reference Type BACKGROUND
PMID: 3181176 (View on PubMed)

Fananapazir L, Cannon RO 3rd, Tripodi D, Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Circulation. 1992 Jun;85(6):2149-61. doi: 10.1161/01.cir.85.6.2149.

Reference Type BACKGROUND
PMID: 1350522 (View on PubMed)

Fananapazir L, Epstein ND, Curiel RV, Panza JA, Tripodi D, McAreavey D. Long-term results of dual-chamber (DDD) pacing in obstructive hypertrophic cardiomyopathy. Evidence for progressive symptomatic and hemodynamic improvement and reduction of left ventricular hypertrophy. Circulation. 1994 Dec;90(6):2731-42. doi: 10.1161/01.cir.90.6.2731.

Reference Type BACKGROUND
PMID: 7994815 (View on PubMed)

Other Identifiers

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96-H-0059

Identifier Type: -

Identifier Source: secondary_id

960059

Identifier Type: -

Identifier Source: org_study_id

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