CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01332162

Acronym

CARDIO-HCM

Enrollment

Registered

2011-04-08

Start date

2013-06-30

Completion date

2020-12-31

Last updated

2016-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Keywords

Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing

Brief 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.

Detailed 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.

Interventions

DEVICEBiventricular pacing

All patients will be pacing during two years

DEVICENo Pacing

No Pacing during the first year. In the second year all patients will be pacing

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).	1 and 2 years	Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)

Secondary

Measure	Time frame	Description
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.	1 and 2 years	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026