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

• ClinicalTrials.gov Identifier: NCT03813511
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2019
• Last Update Posted: October 26, 2021
• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Information provided by (Responsible Party): Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Months
• Official Title: Prevalence and Dynamics of Sleep-Disordered Breathing (SDB) in Patients With Severe Valvular Regurgitation and High Surgical Risk Undergoing Minimally Invasive Clip Procedure
• Actual Study Start Date: December 1, 2018
• Estimated Primary Completion Date: January 31, 2022
• Estimated Study Completion Date: July 31, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation [ Time Frame: 3 month ]
   Proportion of of Sleep disordered breathing in Patiens with severe valvular regurgitation in a given time period
2. Influence of the minimal invasive Clip technique on apnea-hypopnea index [ Time Frame: 3 month ]
   Changes on the number of apnea and hypopnea events per hour of sleep due to the minimal invasiv Clip technique
3. Influence of the minimal invasive Clip technique on apnea index [ Time Frame: 3 month ]
   Changes on the number of apnea events per hour of sleep due to the minimal invasiv Clip technique
4. Influence of the minimal invasive Clip technique on the oxygen desaturation index [ Time Frame: 3 month ]
   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
5. Influence of the minimal invasive Clip technique on T90 [ Time Frame: 3 month ]
   Changes on the the percentage of time during which arterial O2 saturation was less than 90% (T90) due to the minimal invasiv Clip technique
6. Influence of the minimal invasive Clip technique on sleep cycle length [ Time Frame: 3 month ]
   Changes on the duration of the five stages of sleep (in minutes) due to the minimal invasiv Clip technique
7. Influence of the minimal invasive Clip technique on ventilation length during sleep [ Time Frame: 3 month ]
   Changes on the ventilation length (in seconds) due to the minimal invasiv Clip technique
8. Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography [ Time Frame: 3 month ]
   Changes on the proximal isovelocity hemispheric surface area (PISA in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
9. Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography [ Time Frame: 3 month ]
   Changes on the effective regurgitant orifice (ERO in square millimeter) in tranthoracic echocardiography due to the minimal invasiv Clip technique
10. Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography [ Time Frame: 3 month ]
    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
11. Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography [ Time Frame: 3 month ]
    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

Secondary Outcome Measures :

1. Post-interventional changes in daytime sleepiness with and without sleep disordered breathing [ Time Frame: 3 month ]
   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)
2. Post-interventional survey of patient health with and without sleep disordered breathing [ Time Frame: 3 month ]

   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. Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure [ Time Frame: 3 month ]
   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
4. Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing [ Time Frame: 3 month ]
   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
5. Post-interventional assessment of the sleep quality with and without sleep disordered breathing [ Time Frame: 3 month ]
   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))
6. Post-interventional changes in generic health status. with and without sleep disordered breathing [ Time Frame: 3 month ]
   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
7. Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing [ Time Frame: 3 month ]
   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
8. Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing [ Time Frame: 3 month ]
   Post-interventional changes on aerobic capacity and endurance with and without sleep disordered breathing using the six minutes walk test (in meters)
9. Post-interventional changes on cognitive functions with and without sleep disordered breathing [ Time Frame: 3 month ]
   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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Germany

Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum

Bad Oeynhausen, Germany, 32545

Sponsors and Collaborators

Heart and Diabetes Center North-Rhine Westfalia

Investigators

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

More Information

Additional Information:

• Responsible Party: Muhammed Gerçek, Principal Investigator, Heart and Diabetes Center North-Rhine Westfalia
• ClinicalTrials.gov Identifier: NCT03813511
• Other Study ID Numbers: HDZ-KA_015_MG
• First Posted: January 23, 2019
• Last Update Posted: October 26, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia:

Minimally invasive surgery; Clip procedure

Additional relevant MeSH terms:

Respiratory Aspiration; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases