Diagnosis And Treatment of Sleep Apnea in Patient With Heart Failure

NCT02620930 | Unknown

• 1 other identifier: Prot. n. 2013/00 21553
• Study Type: observational
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

DASAP-HF is an observational prospective single arm study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. All patients must sign the Patient Informed Consent (PIC) before the enrollment in the study. All patients, after the enrollment phase, will be followed for 24 months. Approximately every 12 months a clinical follow-up procedure should be performed in each patient. A sleep study will be done in all patients at 1 month (or at 3 months) from the enrollment, in order to evaluate the performance of the algorithm as a diagnostic tool in this population (primary objective). During the 24 months follow-up period, all Adverse Events occurred in the study population will be collected (HF hospitalizations, all-cause deaths, ventricular arrhythmias, etc.). At the end of the 24 months follow-up, the incidence of clinical events will be evaluated as well as its association with the Respiratory Disturbance Index (RDI) values calculated by APNEA Scan algorithm (secondary objective).

Conditions

Sleep Apnea; Heart Failure

Keywords

Sleep Disorders; Sleep Apnea; Apnea-Hypopnea Index (AHI); Respiratory Disturbance Index (RDI)

Outcome Measures

Primary Outcomes (1)

• Severe Sleep Apnea diagnosed with polysomnography

  Primary objective of this study is to evaluate the accuracy of RDI value calculated by APNEA Scan algorithm, as a binary discriminator of severe SA as detected by the gold-standard sleep study.

  27 months

Secondary Outcomes (1)

• Incidence of clinical events

  4 years

Interventions

All market approved CRT-D or ICD systems endowed with the APNEA Scan algorithm DEVICE

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 implanted with an ICD or CRT-D endowed with the APNEA Scan algorithm that meet all inclusion/exclusion criteria.will be enrolled after signing of an informed consent form and an authorization to use and disclose health information.

You may qualify if:

• Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤35%, as documented at the moment of device implant, and conventional indication to CRT-D or ICD.
• Patient implanted with CRT-D or ICD endowed with continuous respiratory sensor designed for sleep apnea monitoring.
• Age 18 or above, or legal age to provide informed consent according to national law.

You may not qualify if:

• Patient on cardiac resynchronization therapy for a period longer than 7 days.
• Woman pregnant or planning to become pregnant.
• Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
• Patient unavailable to attend scheduled follow-up visits at the center.
• Patient life expectancy is less than 12 months.
• Patient is participating in another clinical study that may have an impact on the study endpoints.

Sponsors & Collaborators

• Luigi Padeletti: lead

Study Sites (1)

Department of Heart and Vessels, University of Florence

Florence, 50134, Italy

Location

Related Publications (1)

• Boriani G, Pisano ECL, Pieragnoli P, Locatelli A, Capucci A, Talarico A, Zecchin M, Rapacciuolo A, Piacenti M, Indolfi C, Arias MA, Diemberger I, Checchinato C, La Rovere MT, Sinagra G, Emdin M, Ricci RP, D'Onofrio A. Prognostic value of implantable defibrillator-computed respiratory disturbance index: The DASAP-HF study. Heart Rhythm. 2021 Mar;18(3):374-381. doi: 10.1016/j.hrthm.2020.10.019. Epub 2020 Oct 24.

  PMID: 33283757 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Electrophysiology and Cardiac Pacing

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: March 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: July 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)