Study of sleep related breathing disorders in patients with prolonged heart failure.

Not yet recruiting

• Conditions: Heart failure, unspecified,

• Registration Number: CTRI/2019/04/018454
• Lead Sponsor: LIFE PLUS MEDICAL

Brief Summary

THIS RESEARCH PROJECT HAS BEEN STIMULATED BY ACCUMULATING EVIDENCE THAT SDB DISORDERS ARE IMPORTANT MODIFIERS OF DISEASE PROGRESSION AND TREATMENT IN PATIENTS WITH HEART FAILURE. HEART FAILURE PATIENTS HAVE OCCULT SDB, THEREFORE GO UNDETECTED. THE RESULTS OF THIS STUDY WOULD AID IN DETERMINING THE SAME, MODIFYING TREATMENT STRATEGIES AND ALSO IN ASCERTAINING THE ROLE OF REGULAR SCREENING OF SDB IN CHRONIC HEART FAILURE PATIENTS.

PATIENTS WILL BE SCREENED USING SLEEP APNEA QUESTIONNAIRES. THEY WILL UNDERGO BASIC LAB EVALUATION AND CARDIAC EVALUATION FOLLOWING WHICH THEY WILL BE SUBJECTED TO  OVERNIGHT POLYSOMNOGRAPHY .THE STUDY WILL BE ANALYZED AND THE APNEA HYPOPNEA INDEX (AHI) AND RESPIRATORY DISTURBANCE INDEX (RDI) WILL BE DETERMINED AND PATIENTS WILL BE CLASSIFIED EITHER AS CENTRAL SLEEP APNEA (CSA) OR OBSTRUCTIVE SLEEP APNEA (OSA) . THE PREVALENCE OF SDB  WILL BE DETERMINED IN THE STUDY POPULATION AND THE ABOVE INDICES (AHI,  RDI )WILL BE COMPARED WITH HEART FAILURE SEVERITY CLASS.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-04
• Study Start: 2019-04-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

CHRONIC HEART FAILURE IN-HOSPITAL PATIENTS WHO HAVE RECOVERED FROM AN ACUTE DECOMPENSATION.

Exclusion Criteria

• 1.DECOMPENSATED HEART FAILURE PATIENTS REQUIRING OXYGEN SUPPORT.
• 3.PREGNANT WOMEN.
• 4.PATIENT WITH PREVIOUSLY DIAGNOSED SDB WHO ARE ON THERAPY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PREVALENCE OF SDB, PREVALENCE OF CSA AND OSA, IN CHRONIC HEART FAILURE IN-PATIENTS.	1 YEAR

Secondary Outcome Measures

Name	Time	Method
COMPARISON OF VARIOUS DEMOGRAPHIC PARAMETERS WITH PREVALENCE OF SDB.
CORRELATION OF LV DYSFUNCTION (LVEF) AND NTPROBNP LEVELS WITH AHI AND RDI.
CORRELATION OF ESS SCORES, STOP BANG SCORES, BERLIN QUESTIONNAIRE SCORES WITH AHI AND RDI.
ASSOCIATION OF VARIOUS CO-MORBIDITIES (TYPE 2 DIABETES, HTN, DYSLIPIDEMIA) WITH SDB.

Trial Locations

Locations (1)

KASTURBA HOSPITAL; 🇮🇳 Udupi, KARNATAKA, India

KASTURBA HOSPITAL

🇮🇳Udupi, KARNATAKA, India

SAJIT KISHAN GOLLAPALLI

Principal investigator

9505666002

sajitkishan1234@gmail.com