A Phase 2 interventional study of Dapagliflozin and WatchPat in Heart Failure and Sleep Disordered Breathing, sponsored by Columbia University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Columbia University · Phase 2, Interventional, and Other
Heart Failure is a disease involving many different aspects of the human body, including changes in metabolism, the way the body produces and uses energy. Research shows that patients with heart failure often have a sleep disorder called sleep disordered breathing (SDB). It has been shown that SDB is associated with poor outcomes in heart failure patients, but the exact reason is unknown. It is likely that SDB leads to changes in metabolism and hormone status in the body, which is especially dangerous for heart failure patients. There is currently no treatment for SDB in heart failure patients. Recently, with Sodium glucose co-transporter 2 (SGLT2)-Inhibitors a new drug class has been approved for the treatment of advanced heart failure. This drug has effects on the metabolism in heart failure patients, among several other effects. This research project has the aim to investigate if SGLT2 inhibitors can help in the treatment of SDB, as many mechanisms of the drug overlap with the mechanisms how SDB develops. The drug has been approved by the FDA for the treatment of heart failure. The investigators want to study the effect of the drug on SDB by using a home sleep test called Watchpat, which has been approved to diagnose SDB.
To explore whether SGLT2-Inhibition has a beneficial effect on Sleep Disordered Breathing (SDB) in advanced heart failure patients. This project proposes to carry out research that addresses the established, but in clinical practice under-recognized association between Sleep Disordered Breathing (SDB) and a worse prognosis in patients with heart failure (HF). SDB is highly prevalent in the HF population. Multiple studies have shown that HF accompanied by SDB is associated with an increased mortality compared to the absence of SDB. Two major types of SDB are prevalent in HF: Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA). Mechanistically, it has been proposed that SDB impacts the neurohumoral axis and systemic metabolism and therefore has particularly detrimental effects on the HF patient population. Therapeutic options for the treatment of SDB are limited. Heart Failure is a multisystemic disease leading to maladaptive cardiac and systemic metabolic changes. Recently, with SGLT2-Inhibitors a new drug class has been approved for the treatment of advanced heart failure. This is the first drug class in the HF drug armamentarium targeting cardiometabolic mechanisms. This study seeks to improve the health of individuals with heart failure by exploring whether SGLT2-Inhibition has a beneficial effect on SDB (OSA and CSA) in advanced heart failure patients and therefore may be a novel therapeutic option for the treatment of SDB in advanced HF. The specific aim of this project is to assess the effect of therapy with a SGLT2-I on SDB in ambulatory advanced HF patients by using the WatchPAT-derived apnea-hypopnea index as well as subjective measures of sleep quality using the Berlin Questionnaire and Epworth Sleepiness Scale.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
Browse Heart Failure studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion Criteria:
Patients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)
Drug: Dapagliflozin · Device: WatchPat
If patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy.
Also known as: FARXIGA
HF patients undergo SDB testing with the WatchPat device. (non-experimental)
Change in Apnea-Hypopnea Index
Change in the apnea-hypopnea index as measured by the WatchPAT device.
Time frame: 6 months
Change Berlin Questionnaire Categorization
The Berlin Questionnaire for sleep apnea consists of 3 categories related to the risk of having sleep apnea. Participants are classified as "High Risk" or "Low Risk" for sleep apnea. High risk categorization is assigned when there are 2 or more categories where the score is positive ("positive" defined as a score of 2 or more points). Low risk categorization is assigned when there is 1 or no categories where the score is positive.
Time frame: 6 months
Change in Epworth Sleepiness Scale
The Epworth Sleepiness Scale is an 8-item scale measuring sleepiness in various situations. Each situation is scored as 0=no chance of dozing to 3= high chance of dosing. Scores range from 0-24, with a higher score indicating a higher level of sleepiness.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Aug 2025, 20 months later.
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin