Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks.

Start Date29 Aug 2023

Sponsor / Collaborator

Gentofte University Hospital

[+2]

NCT05448274

/ CompletedNot ApplicableIIT

An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

Start Date03 May 2023

Sponsor / Collaborator

Gentofte University Hospital

[+3]

NCT05788601

/ Active, not recruitingPhase 2IIT

Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial

This study is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, parallel-group, single-centre clinical trial investigating the body weight loss potential of dapiglutide, a dual GLP-1R/GLP-2R agonist, administered subcutaneously once weekly. The study will investigate the efficacy of once-weekly subcutaneously administered of 4 mg and 6 mg dapiglutide versus placebo in 54 obese individuals (BMI >30 kg/m2) during a 12-week treatment period.

Start Date27 Apr 2023

Sponsor / Collaborator

Gentofte University Hospital

[+1]

100 Clinical Results associated with Gentofte University Hospital

0 Patents (Medical) associated with Gentofte University Hospital

1,087

Literatures (Medical) associated with Gentofte University Hospital

12 Nov 2024·Circulation

Abstract 4147572: Sex, Adiposity-Related Anthropometrics, and Clinical Outcomes in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Participant-Level Pooled Analysis of Randomized Trials

Author: Desai, Akshay ; Vaduganathan, Muthiah ; Claggett, Brian ; Ostrominski, John ; Butt, Jawad ; Lassen, Mats ; Solomon, Scott ; Anand, Inder ; Jhund, Pardeep ; Zile, Michael ; McMurray, John ; ZANNAD, Faiez ; Pfeffer, Marc ; Pitt, Bertram ; Lam, Carolyn

Background: Important sex-related differences in body composition exist and may influence the predictive utility of body mass index (BMI) in heart failure (HF) populations. However, whether sex modifies the association between BMI and other adiposity-related anthropometrics and outcomes in HF with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) has not been rigorously explored. Methods: In this participant-level pooled analysis of five international, multicenter, randomized-controlled trials enrolling adults HFmrEF/HFpEF, the association between sex and adiposity-related anthropometrics (BMI, waist circumference [WC], and waist-to-height ratio [WHtR]) and the primary composite outcome of time-to-first HF hospitalization or cardiovascular (CV) death was evaluated using multivariable adjusted Cox proportional hazards models (stratified by age, treatment, and trial) and restricted cubic splines. Results: Overall, BMI was available in 21,606 participants (mean age, 71±9 years; 83% White; mean BMI: 30±6 kg/m 2 ), of whom 10,681 (49%) were female and 10,925 (51%) were male. WC was available in 7,854 participants. Female participants were more likely to be older, have higher BMI, WHtR, and left ventricular ejection fraction. Males had higher rates of the primary outcome compared with females across the BMI, WC, and WHtR spectra ( Pcomparison <0.01 for all), but higher BMI, WC, and WHtR were similarly associated with a higher rate of the primary outcome irrespective of sex ( Figure ). However, among those with BMI 18.5 to <25 kg/m 2 , WC was elevated in 8% of males, but 34% of females. Higher WC was associated with a higher rate of primary events (adjusted hazard ratio per 10 cm increase, 1.13, 95% CI 1.08-1.19; P <0.001) independent of BMI, with consistent findings by sex ( Pinteraction =0.25). Conclusions: In this participant-level pooled analysis of HFmrEF/HFpEF trials, higher BMI, WC, and WHtR were similarly associated with HF hospitalization or CV death in females and males. However, use of BMI alone disproportionately underestimated abdominal adiposity among females, stressing the importance of implementing additional anthropometrics to mitigate sex-based differences in risk stratification in the HF population.

12 Nov 2024·Circulation

Abstract 4140656: Educational Attainment Level and Risk of Mortality and Cardiopulmonary Outcomes in High-Risk Cardiovascular Disease Patients: The INVESTED Trial

Author: Claggett, Brian ; Lassen, Mats ; Solomon, Scott ; Vardeny, Orly ; Joseph, Jacob ; Howell, Nicholas ; Udell, Jacob ; Hegde, Sheila ; Biering-Srensen, Tor

Background: Social determinants, such as educational attainment level (EAL), are indicators of socioeconomic status and have been shown to be inversely related with adverse health outcomes. However, the association between EAL and risk of cardio-pulmonary events in heart failure (HF) and myocardial infarction (MI) survivors has not been extensively investigated. Methods: In the INVESTED trial, 5260 patients from the US and Canada with recent HF or MI hospitalization were randomized 1:1 to high-dose trivalent or standard-dose quadrivalent influenza vaccine from Sep 2016 to Jan 2019. We examined the association between EAL and risk of adverse clinical outcomes for each participant across all enrolling seasons using Cox models adjusted for treatment assignment and clinically relevant confounders and stratified by trial entry year. Participants were categorized by EAL (high school or less [HS], post-high school or trade [post-HS/T], and college or more [Col+]). Results: Of the 4,912 participants (mean age: 65.5 years, 28% females, 80% White, 39% with MI and 61% with HF hospitalization as qualifying event) with EAL information, 43% were in the HS group, 28% were in the post-HS/T group, and 29% were in the Col+ group. At baseline, those with higher EAL were more likely to be White or Asian, be married/with long-term partner, have higher left ventricular ejection fraction, have lower NYHA class, and less likely to have cardiovascular comorbidities and risk factors than those with lower EAL. During follow-up (median: 9 months [6-16]), 1,706 (35%) participants experienced the composite of all-cause death or cardiopulmonary hospitalization. Compared to HS, higher EAL was associated with a stepwise decrease in the risk of the composite outcome (post-HS/T: HR: 0.88 95%CI: [0.79-0.99]; Col+: HR: 0.71 95%CI: [0.63-0.81], overall p-value <0.001). A similar protective effect of higher EAL was observed for additional adverse clinical outcomes ( Figure ). Conclusion: High EAL is independently associated with a decreased risk of adverse clinical outcomes in patients with high-risk cardiovascular disease, highlighting the need to consider EAL in risk assessment and target additional resources towards those with low EAL to improve prognosis.

12 Nov 2024·Circulation

Abstract 4127562: Age, Adiposity-Related Anthropometrics, and Clinical Outcomes in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Participant-Level Pooled Analysis of Randomized Trials

Author: Desai, Akshay ; Vaduganathan, Muthiah ; Claggett, Brian ; Ostrominski, John ; Butt, Jawad ; Lassen, Mats ; Solomon, Scott ; Jhund, Pardeep ; Anand, Inder ; Zile, Michael ; McMurray, John ; Pfeffer, Marc ; ZANNAD, Faiez ; Pitt, Bertram ; Lam, Carolyn

Background: Age has been shown to modify the population-level association between body mass index (BMI) and mortality. However, whether age modifies the association between adiposity-related anthropometrics and adverse outcomes in heart failure (HF) populations has not been systematically explored. Methods: In this participant-level pooled analysis of five international, multicenter, randomized-controlled trials enrolling adults with HF and either mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), the association between age and adiposity-related anthropometrics (BMI, waist circumference [WC], and waist-to-height ratio [WHtR]) and the primary composite outcome of time-to-first HF hospitalization or cardiovascular (CV) death was evaluated using multivariable adjusted Cox proportional hazards models (stratified by treatment and trial) and restricted cubic splines. Results: Among 21,606 participants in the analysis (mean age, 71±9 years; 49% female; 83% White; mean BMI, 30±6 kg/m 2 ), 5,350 (25%) were aged <65 years, 8,273 (38%) were aged 65-74 years, and 7,983 (37%) were aged ≥75 years at baseline. Older individuals were more likely to be female, have lower BMI and WC, and higher left ventricular ejection fraction. Overall, BMI, WC, and WHtR were steeply and non-linearly associated with the primary outcome ( Figure ). Age, as either a categorical or continuous variable, significantly modified the covariate-adjusted association between all anthropometrics and the primary composite outcome ( P ≤0.001 for all) ( Figure ). A J-shaped relationship, characterized by higher incidence of the primary outcome with lower anthropometric values, was observed only for BMI and was substantially attenuated among younger adults. Irrespective of the anthropometric used, increasing adiposity was most steeply associated with primary events among adults aged <65 years. Conclusions: In this pooled analysis of HFmrEF/HFpEF trials, age was a powerful modifier of the relationship between excess adiposity and HF hospitalization or CV death. An “obesity-survival paradox” – observed only for BMI – was not apparent in younger participants, who exhibited the steepest increase in the rate of clinical events with higher adiposity.

100 Deals associated with Gentofte University Hospital

100 Translational Medicine associated with Gentofte University Hospital

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