Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
- Registration Number
- NCT04788511
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.
Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.
During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.
The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 529
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to 30.0 kg/m^2
- New York Heart Association (NYHA) Class II-IV
- Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide Semaglutide All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose. Placebo (semaglutide) Placebo (semaglutide) All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
- Primary Outcome Measures
Name Time Method Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) From baseline (week 0) to end of treatment (week 52) The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in Body Weight From baseline (week 0) to end of treatment (week 52) Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
- Secondary Outcome Measures
Name Time Method The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs From baseline (week 0) to end of study (week 57) The hierarchical composite outcome measure from baseline (week 0) to end of study (week 57) consists of the components: time to all-cause death, number of heart failure events requiring hospitalization or urgent heart failure visit, time to first heart failure event requiring hospitalization or urgent heart failure visit, difference at least 15 in KCCQ CSS change from baseline to 52 weeks, difference at least 10 in KCCQ CSS change from baseline to 52 weeks, difference at least 5 in KCCQ CSS change from baseline to 52 weeks and difference at least 30 meters in six-minute walking distance change from baseline to 52 weeks. It was analyzed by the win-ratio approach using all participants pairs across treatment groups. Overall summary of wins in each treatment group is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in C-Reactive Protein (CRP): Ratio to Baseline From baseline (week -2) to end of treatment (week 52) Change in high sensitivity C-reactive protein measured in ratio of C-reactive protein to baseline (week -2) at end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Achieving 15% Weight Loss (Yes/No) From baseline (week 0) to end of treatment (week 52) Percentage of participants who achieved 15% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 15% weight loss whereas 'No' infers percentage of participants who have not achieved 15% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S) From baseline (week 0) to end of treatment (week 52) The patient global impression of status (PGI-S) for KCCQ was used to rate participants' symptoms of heart failure using 4-category ordinal scale (no symptoms, mild, moderate, severe). KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. OSS and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. Outcome measure was evaluated based on data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as mean change in KCCQ-CSS in those participants with one-category improvement in PGI-S from baseline to week 52.
Change in Six-minute Walking Distance (6MWD) From baseline (week 0) to end of treatment (week 52) Observed mean change from baseline (week 0) in 6 minutes walking distance (6MWD) test to end of treatment (week 52) is presented. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) From baseline (week 0) to end of treatment (week 52) Percentage of participants who achieved 10% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 10% weight loss whereas 'No' infers percentage of participants who have not achieved 10% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Achieving 20% Weight Loss (Yes/No) From baseline (week 0) to end of treatment (week 52) Percentage of participants who achieved 20% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 20% weight loss whereas 'No' infers percentage of participants who have not achieved 20% weight loss The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) From baseline (week 0) to end of treatment (week 52) Percentage of participants improving 10 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 10 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) From baseline (week 0) to end of treatment (week 52) Percentage of participants improving 5 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In the reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 5 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in Systolic Blood Pressure (SBP) From baseline (week -2) to end of treatment (week 52) Observed mean change in systolic blood pressure from baseline (week -2) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in Waist Circumference From baseline (week 0) to end of treatment (visit 52) Change waist circumference from baseline (week 0) to end of the treatment (visit 52) presented. Waist circumference is defined as the abdominal circumference located midway between the lower rib margin and the iliac crest. Measurement must be obtained in standing position with a non-stretchable measuring tape and to the nearest cm or inch. The tape should touch the skin but not compress soft tissue and twists in the tape should be avoided. The participant should be asked to breathe normally. The same measuring tape should be used throughout the trial. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Change in KCCQ Overall Summary Score (KCCQ-OSS) From baseline (week 0) to end of treatment (week 52) The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ while KCCQ-OSS includes the symptom, physical limitation, quality of life, and social limitation domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S) From baseline (week 0) to end of treatment (week 52) Observed mean change from baseline in 6 minutes walking distance (6MWD) test using PGI-S is evaluated for this outcome measure. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as the mean change in 6MWD in those participants with an one-category improvement in PGI-S from baseline to week 52.
Trial Locations
- Locations (90)
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Eastern Shore Rsrch Inst, LLC
🇺🇸Fairhope, Alabama, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
The Research Group of Lexington LLC
🇺🇸Lexington, Kentucky, United States
Cotton-O'Neil Heart Center
🇺🇸Topeka, Kansas, United States
Aarhus Universitetshospital, Skejby Hjertesygdomme
🇩🇰Aarhus N, Denmark
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Northwest Heart Clinical Research, LLC
🇺🇸Arlington Heights, Illinois, United States
Northwestern University_Chicago_0
🇺🇸Evanston, Illinois, United States
Gelre Ziekenhuizen Apeldoorn
🇳🇱Apeldoorn, Netherlands
Rode Kruis Ziekenhuis Beverwijk
🇳🇱Beverwijk, Netherlands
Chicago Medical Research LLC
🇺🇸Hazel Crest, Illinois, United States
Heart Clinic of Hammond
🇺🇸Hammond, Louisiana, United States
Hospital of University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MVZ CCB Frankfurt Und Main-Taunus GbR
🇩🇪Frankfurt, Germany
Kardiologisk Odense & Svendborg
🇩🇰Svendborg, Denmark
Southmead Hospital
🇬🇧Bristol, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Glasgow Clinical Research Facility
🇬🇧Glasgow, United Kingdom
Hospital Universitario La Zarzuela
🇪🇸Madrid, Spain
Sheba Medica Center - Clinical Research Unit
🇮🇱Tel Hashomer, Israel
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, United Kingdom
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Great Western Hospital
🇬🇧Swindon, United Kingdom
St. Richards Hospital
🇬🇧West Sussex, United Kingdom
Manchester Royal Infirmary_Manchester_0
🇬🇧Manchester, United Kingdom
Charite Universitatsmedizin Berlin KöR
🇩🇪Berlin, Germany
Semmelweis Egyetem Szent Rókus Klinikai Tömb
🇭🇺Budapest, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászat
🇭🇺Budapest, Hungary
Jahn Ferenc Dél-pesti Kórház és Rendelőintézet
🇭🇺Budapest, Hungary
Baptist Health Louisville
🇺🇸Louisville, Kentucky, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Lindner Center,Christ Hospital
🇺🇸Cincinnati, Ohio, United States
St Louis Heart & Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
NY Presbyt Hosp-W Cornell Med
🇺🇸New York, New York, United States
St Francis Hospital Lindner Research Center
🇺🇸Greenvale, New York, United States
Instituto de Cardiología de Corrientes
🇦🇷Corrientes, Argentina
Centro de Investigación y Prevención Cardiovascular
🇦🇷Caba, Argentina
Sanatorio Britanico S.A.
🇦🇷Rosario, Santa Fe, Argentina
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
The Canberra Hospital_Garran
🇦🇺Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital - Cardiology
🇦🇺Concord, New South Wales, Australia
Cambridge Cardiac Care Centre
🇨🇦Cambridge, Ontario, Canada
Heart Health Institute Research, Inc.
🇨🇦Scarborough, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie. de Quebec - Universite Laval
🇨🇦Quebec, Canada
Nemocnice Jihlava Kardiologie
🇨🇿Jihlava, Czechia
Vseobecna fakultni nemocnice a 1 LF UK v Praze
🇨🇿Praha 2, Czechia
IKEM
🇨🇿Praha 4, Czechia
Poliklinika Holešovice VISIONARY - MEDICON a.s.
🇨🇿Praha 7, Czechia
Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o.
🇨🇿Praha 7, Czechia
Nemocnice Slany Kardiologie
🇨🇿Slany, Czechia
Nemocnice Tábor a.s.
🇨🇿Tábor, Czechia
Herlev og Gentofte Hospital
🇩🇰Hellerup, Region Hovedstaden, Denmark
Zentrum fuer klinische Studien Suedbrandenburg GmbH
🇩🇪Elsterwerda, Germany
Lausmed Kft.
🇭🇺Baja, Bács-Kiskun Vármegye, Hungary
Selye János Kórház
🇭🇺Komárom, Komárom-Esztergom, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
🇭🇺Budapest, Hungary
Gottsegen György Országos Kardiológiai Intézet
🇭🇺Budapest, Hungary
Heart Failure Unit, Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Bravis Ziekenhuis
🇳🇱Roosendaal, Netherlands
Borsod-Abaúj-Zemplén Megyei Központi Kórház
🇭🇺Miskolc, Hungary
UMC Groningen
🇳🇱Groningen, Netherlands
Saxenburgh Medisch Centrum
🇳🇱Hardenberg, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Cardiología Palermo
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Medical Center - University Of Freiburg
🇩🇪Freiburg, Germany
Appel
🇩🇪Kassel, Germany
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Hungary
Cardiology department, Western Galilee Medical Center
🇮🇱Nahariya, Israel
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
🇵🇱Lodz, Lodzkie, Poland
Malopolskie Centrum Sercowo-Naczyniowe
🇵🇱Chrzanow, Malopolskie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio
🇵🇱Bialystok, Podlaskie, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
🇵🇱Gdynia, Poland
I Katedra i Klinika Kardiologii WUM SPCSK
🇵🇱Warsaw, Poland
Pro Familia Altera Sp. z o.o.
🇵🇱Katowice, Śląskie, Poland
CEMEDIC
🇦🇷Caba, Argentina
Consultorio Integral de Atención al Diabético
🇦🇷Morón, Argentina
Partnrs Adv Cardio Eval (PACE)
🇨🇦Newmarket, Ontario, Canada
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
🇩🇪Dresden, Germany
Universitatsklinikum Wurzburg AöR
🇩🇪Würzburg, Germany
Hadassah Ein Kerem MC - Cardio
🇮🇱Jerusalem, Israel
Cardio Vascular Research Center Sourasky MC
🇮🇱Tel Aviv, Israel
Geelong Cardiology Research Unit
🇦🇺Geelong, Victoria, Australia
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States