Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure (ClipSDB)

Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure

In a prospective observational study, the investigators investigate the prevalence of sleep disordered breathing in patients with severe valvular regurgitation and the effect of using the minimal invasive Clip technique on sleep disordered breathing.

Study Overview

• Status: Completed
• Conditions: Sleep Disordered Breathing; Valvular Regurgitation

Detailed Description

The purpose of this study is to analyze the prevalance of sleep disordered breathing in patients with severe valvular regurgitation and the impact of a therapy with the minimal-invasive Clip technique.

Therefore, the investigators want to include consecutive patients with unknown sleep-associated respiratory distress syndrome and, in addition, as a study-specific achievement, the investigators want to obtain the quality of life and specific symptoms of the patients by using established questionnaires. After three month of post-interventional care, the patients will get a post-interventional check-up in our cardiological outpatient clinic, where the course of sleep-associated respiratory distress syndrome and the actual quality of life and specific symptoms will be documented by using a cardiorespiratory polygraphy and the same questionnaires.

The entire hospital stay, including possible post-interventional complications, will be documented for this study from the patients' medical records. The routine examinations (laboratory values, ECG, 6-minute walk test, pulmonary function examinations, spiroergometry, transthoracic / -oesophageal echocardiography, etc.) shall also be recorded in the database of this study.

The plan is to include 100 evaluable patients with complete follow-up and the associated test results. For this purpose, a screening of 150 patients is expected to be required.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stationäre patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique

Description

Inclusion Criteria:

• Patients with severe valvular regurgitation and currently unknown sleep disorder breathing who will be treated with a minimal invasive Clip technique

Exclusion Criteria:

• Patients with more then one valvular disease which requires Treatment
• Patients with complex congenital heart disease
• Pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation	Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period	3 month
Influence of the minimal invasive Clip technique on apnea-hypopnea index	Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on apnea index	Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on the oxygen desaturation index	Changes on the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on T90	Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on sleep cycle length	Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on ventilation length during sleep	Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography	Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography	Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography	Changes on the peak velocity of the mitral regurgitant jet (mR-Vmax in meter per seconds) in tranthoracic echocardiography due to the minimal invasiv Clip technique	3 month
Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography	Changes on systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function (without unity) in tranthoracic echocardiography due to the minimal invasiv Clip technique	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-interventional changes in daytime sleepiness with and without sleep disordered breathing	Post-interventional changes in daytime sleepiness with and without sleep disordered breathing measured by the Epworth Sleepinss Scale (ESS) (From 0 to 24 point-scale; A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates severe daytime sleepiness)	3 month
Post-interventional survey of patient health with and without sleep disordered breathing	Post-interventional survey of patient health with and without sleep disordered breathing measured by the Short Form (36) Health Survey (SF-36). SF-36 consists of eight scaled score (Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health). Total range from 0 to 100 points (from worst to best)	3 month
Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure	Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) that hat quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Total range is from 0 to 100 points. 0 denotes the worst and 100 the best possible health status	3 month
Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing	Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing using the Minnesota Living with Heart Failure Questionnaire. It provides a total score range 0-105, from best to worst	3 month
Post-interventional assessment of the sleep quality with and without sleep disordered breathing	Post-interventional assessment of the sleep quality with and without sleep disordered breathing using the Pittsburgh Sleep Quality Index (PSQI) (From 0 (worst) to 21 (best))	3 month
Post-interventional changes in generic health status. with and without sleep disordered breathing	Post-interventional changes in generic health status. with and without sleep disordered breathing using the EQ-5D questionnaire (grade ranging from 0, the worst possible health status, to 100 ,the best possible health status	3 month
Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing	Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram	3 month
Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing	Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the six minutes walk test (in meters)	3 month
Post-interventional changes on cognitive functions with and without sleep disordered breathing	Post-interventional changes on cognitive functions with and without sleep disordered breathing using the Montreal Cognitive Assessment Test (MOCA) (From 0 (worst) to 30 (best) point-scale)	3 month

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Investigators: Principal Investigator: Muhammed Gercek, MD, Heart and Diabetes Center North Rhine-Westphalia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 19, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Clip procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: HDZ-KA_015_MG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No