CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Hypertrophic Obstructive Cardiomyopathy (HOCM) Clinical Trial

— CARDIO-HCM  

Official title:

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01332162
• Other study ID #: CRT-01-2011-HCPB
• Status: Recruiting
• Phase: Phase 2
• First received: April 1, 2011
• Last updated: October 19, 2016
• Start date: June 2013
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

Description:

In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

Exclusion Criteria:

• HOCM intraventricular gradient < 50mmHg

• LV ejection fraction < 50%

• mild symptoms

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy (HOCM)
• Hypertrophy

Intervention

Device:
• Biventricular pacing
All patients will be pacing during two years
• No Pacing
No Pacing during the first year. In the second year all patients will be pacing

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).	Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)	1 and 2 years
Secondary	Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.	Change from Baseline in Clinical evaluation (New York Heart Association(NYHA), Quality of life Questionnaire (QoL), 6 Minutes Walk Test (6MWT)), interventricular septum thickness, posterior wall thickness, provoked left ventricular outflow tract gradient, mitral regurgitation grade.	1 and 2 years