Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00725595
• Other study ID #: 092801
• Secondary ID: 20070928No 09280
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2008
• Last updated: August 25, 2008
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2008
• Source: Nanjing Medical University
• Contact: Zhang Xilong, PhD
• Phone: 96-25-83714511
• Email: zhangxilong1952[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States

2. Subject is > 18 years old

3. Patients with known history of CSR. CSR symptoms may include the following:

• sleep fragmentation as reported by patient or as witnessed by another person

• night arousal after apneic episodes

• reduced exercise capacity

• daytime sleepiness

4. Expected to tolerate the ventilator therapy

Exclusion Criteria:

1. Baseline oxygen saturation < 90% on a stable FIO2)

2. Patient is currently enrolled in another clinical study which may confound the results of this study

3. Patient for whom informed consent cannot be obtained

4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure

5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)

6. Patients with severe COPD (per GOLD scale)

7. Patients with a history of myocardial infarction within the 6 months prior to the study

8. Patients with unstable angina

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Heart Failure
• Sleep Apnea

Locations

Country	Name	City	State
China	The 1st Affiliated Hospitak of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhang XL, Yin KS, Jiang SS, Li XL, Jia EZ, Su M. [Efficacy of adaptive pressure support servo-ventilation in patients with congestive heart failure and Cheyne-Stokes respiration]. Zhonghua Yi Xue Za Zhi. 2006 Jun 20;86(23):1620-3. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Both ASV and Bilevel ventilation are effective in clinical treatment of CSR		three months	No
Secondary	ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure		three months	No

External Links

•   CSR and heart failure