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Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

Primary Purpose

Cardiomyopathy, Hypertrophic

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiomyopathy, Hypertrophic focused on measuring Cardiac Hypertrophy, Drug-Refractory, Hemodynamic Benefits, Obstruction, Pacemaker Therapy, Hypertrophic Cardiomyopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Group 1: HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms. Group 2: HCM patients selected from Group 1 who at the follow-up cardiac catheterization are demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction (greater than 50% reduction in LVOT gradient). Patient who have developed a heart block will be excluded from group 2. Females must have a negative pregnancy test.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001530
Brief Title
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Official Title
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Study Type
Observational

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Hypertrophic
Keywords
Cardiac Hypertrophy, Drug-Refractory, Hemodynamic Benefits, Obstruction, Pacemaker Therapy, Hypertrophic Cardiomyopathy

7. Study Design

Enrollment
120 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Group 1: HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms. Group 2: HCM patients selected from Group 1 who at the follow-up cardiac catheterization are demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction (greater than 50% reduction in LVOT gradient). Patient who have developed a heart block will be excluded from group 2. Females must have a negative pregnancy test.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3181176
Citation
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.
Results Reference
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PubMed Identifier
1350522
Citation
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.
Results Reference
background
PubMed Identifier
7994815
Citation
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.
Results Reference
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Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

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