Clinical trial NCT03813511: Sleep-Disordered Breathing in Patients With Severe Valvular Regurgitation Undergoing Clip Procedure
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disordered Breathing
Valvular Regurgitation
Keywords: Minimally invasive surgery
Clip procedure
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalance of Sleep disordered breathing in Patiens with severe valvular regurgitation
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on apnea-hypopnea index
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on apnea index
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on the oxygen desaturation index
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on T90
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on sleep cycle length
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on ventilation length during sleep
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on PISA in tranthoracic echocardiography
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on the effective regurgitant orifice (ERO) in tranthoracic echocardiography
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on the peak velocity of the mitral regurgitant jet (mR-Vmax) in tranthoracic echocardiography
timeFrame: 3 month
measure: Influence of the minimal invasive Clip technique on the myocardial perfomance index (TEI-index) in tranthoracic echocardiography
timeFrame: 3 month
Secondary outcomes:
measure: Post-interventional changes in daytime sleepiness with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional survey of patient health with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional assesment of Symptoms, function and quallity of life with and without sleep disordered breathing by patients with heart failure
timeFrame: 3 month
measure: Post-interventional measurement of the adverse effects of heart failure on patient's life with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional assessment of the sleep quality with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional changes in generic health status. with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional changes aerobic capacity and endurance with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional changes functional capacity of cardiopulmonary and musculoskeletal system with and without sleep disordered breathing
timeFrame: 3 month
measure: Post-interventional changes on cognitive functions with and without sleep disordered breathing
timeFrame: 3 month
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum
Study officials:
affiliation: Heart and Diabetes Center North Rhine-Westphalia
name: Muhammed Gercek, MD
role: PRINCIPAL_INVESTIGATOR
References: