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Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy (CPAPandHCM)

Primary Purpose

Non-obstructive Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-obstructive Hypertrophic Cardiomyopathy focused on measuring CPAP, Hypertrophic cardiomyopathy, Blood Pressure, The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • both genders
  • over 18 years-old
  • hemodynamically stable
  • with no other cardiac disease
  • consent form signed

Exclusion Criteria:

  • presence of pacemaker
  • spontaneous withdrawal
  • previous cardiorespiratory arrest
  • atrial fibrilation during echocardiography

Sites / Locations

  • Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Low CPAP pressure

High CPAP pressure

Arm Description

Patients are submmited to a CPAP with low pressure for 20 minutes

Patients are submmited to a high pressure of CPAP for 20 minutes

Outcomes

Primary Outcome Measures

Cadiac performance by echocardiography

Secondary Outcome Measures

Full Information

First Posted
June 26, 2012
Last Updated
December 18, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01631006
Brief Title
Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy
Acronym
CPAPandHCM
Official Title
Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome. Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life. Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy
Keywords
CPAP, Hypertrophic cardiomyopathy, Blood Pressure, The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low CPAP pressure
Arm Type
Sham Comparator
Arm Description
Patients are submmited to a CPAP with low pressure for 20 minutes
Arm Title
High CPAP pressure
Arm Type
Active Comparator
Arm Description
Patients are submmited to a high pressure of CPAP for 20 minutes
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
A low or high CPAP pressure is delivered for 20 minutes
Primary Outcome Measure Information:
Title
Cadiac performance by echocardiography
Time Frame
acutely

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: both genders over 18 years-old hemodynamically stable with no other cardiac disease consent form signed Exclusion Criteria: presence of pacemaker spontaneous withdrawal previous cardiorespiratory arrest atrial fibrilation during echocardiography
Facility Information:
Facility Name
Heart Institute
City
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27167210
Citation
Nerbass FB, Salemi VMC, Pedrosa RP, Portilho NP, Ferreira-Filho JCA, Moriya HT, Antunes MO, Arteaga-Fernandez E, Drager LF, Lorenzi-Filho G. Acute Effects of Nasal CPAP in Patients With Hypertrophic Cardiomyopathy. Chest. 2016 Nov;150(5):1050-1058. doi: 10.1016/j.chest.2016.05.004. Epub 2016 May 7.
Results Reference
derived

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Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy

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