Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

NCT01657188 | Completed

• 1 other identifier: HDZNRW_KA_001_OO
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.

Conditions

Heart Failure, Congestive; Sleep Apnea Syndromes; Adaptive Servoventilation

Keywords

Heart failure, congestive; Sleep apnea syndromes; Adaptive servoventilation; Prognosis; Cheyne-Stokes respiration

Outcome Measures

Primary Outcomes (1)

• Influence of adaptive servoventilation on heart failure parameters including event free survival

  This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome.

  Time frame for event free survival analysis is up to 8 years

Study Arms (1)

Heart failure, sleep-disordered breathing

Patients with stable heart failure NYHA ≥ II, EF ≤ 45% with or without central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation

Device: Cheyne-Stokes respiration by adaptive servoventilation

Interventions

Cheyne-Stokes respiration by adaptive servoventilation DEVICE

Heart failure, sleep-disordered breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of a university hospital

You may qualify if:

• Stable heart failure NYHA ≥ II
• EF ≤ 45%
• without sleep-disordered breathing (apnea-hypopnea-index \<5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy

You may not qualify if:

• Cardiac resynchronization or pacemaker implantation within the last 6 months
• Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)\< 70% (GOLD III)
• Respiratory insufficiency requiring long-term oxygen therapy
• Daytime hypercapnia at rest (pCO2 \> 45 mmHg)
• Current ventilation therapy
• Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization
• Acute myocarditis within 6 months prior to randomization
• Pregnancy

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

Bad Oeynhausen, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes; Cheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olaf Oldenburg, M.D.

  Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior cardiologist

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2009
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

DE (1)