Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity (DUAL-HFrEF)
30. juli 2026 opdateret af: Shadi Shafaghi, Shahid Beheshti University of Medical Sciences
Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity: A Double-Blinded Randomized Controlled Trial
The goal of this clinical trial is to learn if tirzepatide works to improve physical function in adults with heart failure and obesity. It will also learn about the safety of tirzepatide. The main questions it aims to answer are:
Does tirzepatide improve how far participants can walk in 6 minutes? Does tirzepatide improve heart failure symptoms and quality of life? What side effects do participants have when taking tirzepatide?
Researchers will compare tirzepatide to a placebo (a look-alike substance that contains no drug) to see if tirzepatide improves physical function in people with heart failure and obesity.
Participants will:
Get a weekly injection of tirzepatide or a placebo under the skin for 6 months Start at a low dose, which may be raised slowly based on how well they tolerate it Keep taking their usual heart failure medicines Visit the clinic for checkups, blood tests, heart ultrasounds, and a 6-minute walk test Answer questions about their quality of life and heart failure symptoms
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
This is a phase 3, randomized, double-blind (participant, care provider, investigator, and outcomes assessor blinded), placebo-controlled, parallel- group clinical trial evaluating the efficacy and safety of tirzepatide, a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, in participants with heart failure with reduced ejection fraction (HFrEF) and obesity.
Eligible participants are adults aged 18 years or older with HFrEF (left ventricular ejection fraction ≤40% on echocardiography within the prior 3 months), a body mass index ≥27 kg/m² with at least one obesity-related comorbidity (hypertension, diabetes, or dyslipidemia), and stable guideline-directed heart failure therapy for at least 4 weeks prior to enrollment. Key exclusion criteria include recent acute heart failure decompensation or hospitalization, uncontrolled blood pressure, advanced kidney disease (eGFR <30 mL/min/1.73m²), significant hepatic impairment, active pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, and pregnancy or breastfeeding.
A total of 60 participants will be randomized 1:1 using a computer-generated block randomization schedule (block size of 4) to receive either tirzepatide or matching placebo, both administered as weekly subcutaneous injections. Study drug is initiated at 2.5 mg once weekly and titrated every 4 weeks, as tolerated, up to a maximum of 10 mg once weekly, continuing through month 6. The placebo pen is identical in appearance, packaging, and dosing schedule to maintain blinding.
The primary outcome is change in 6-minute walk distance from baseline to 6 months. Secondary outcomes include change in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire quality-of-life score, body mass index, ejection fraction, pulmonary artery pressure, and metabolic parameters (fasting glucose, glycated hemoglobin, lipid panel), measured at baseline and at months 2, 4, and 6. Safety outcomes include gastrointestinal adverse events, injection-site reactions, hypoglycemia, pancreatitis, gallbladder events, and changes in liver enzymes, amylase, and lipase. An exploratory outcome evaluates shared molecular and genetic pathways linking obesity and HFrEF using peripheral blood RNA analysis via quantitative PCR or next-generation sequencing.
The study is being conducted at seven sites in Tehran, Iran, including Masih Daneshvari Hospital, Shahid Rajaei Cardiovascular Medical and Research Center, Rasoul Akram Hospital, Tehran Heart Center, Firoozgar Hospital, Ayatollah Taleghani Hospital, and Imam Khomeini Hospital Complex.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Shadi Shafaghi, MD-MPH-PhD
- Telefonnummer: 989125901135
- E-mail: shafaghishadi@yahoo.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Heart failure with reduced ejection fraction, defined as left ventricular ejection fraction ≤40% on echocardiography performed within the prior 3 months
- Body mass index ≥27 kg/m², with at least one obesity-related comorbidity (hypertension, diabetes, or dyslipidemia)
- Stable heart failure therapy for at least 4 weeks prior to enrollment, including beta-blockers, renin-angiotensin system inhibitors/angiotensin receptor-neprilysin inhibitors, and sodium-glucose cotransporter-2 inhibitors, if prescribed
- Written informed consent
Exclusion Criteria:
- Acute heart failure decompensation or cardiac hospitalization within the prior 4 weeks
- Uncontrolled blood pressure (systolic blood pressure <90 mmHg or ≥180 mmHg)
- Advanced renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m²)
- Severe hepatic impairment (liver enzymes elevated to 3 times the upper limit of normal)
- Active pancreatitis
- Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Pregnancy or breastfeeding
- Known hypersensitivity to glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist drugs
- Concurrent use of other weight-loss medications
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Tirzepatide
Participants receive tirzepatide via prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy.
Starting dose is 2.5 mg once weekly for 4 weeks, titrated based on tolerability every 4 weeks up to a maximum of 10 mg once weekly, continued through month 6.
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dual GLP-1/GIP receptor agonist administered subcutaneously; brief dosing summary
Andre navne:
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Placebo komparator: Placebo
Participants receive matching placebo via identical prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy, with the same dosing schedule and titration pattern as the tirzepatide group, continued through month 6.
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Matching placebo pen containing all inactive ingredients except tirzepatide
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in 6-Minute Walk Distance
Tidsramme: Baseline and 6 months after intervention start
|
The 6-minute walk test will be performed according to the American Thoracic Society standard guidelines in a straight 30-meter corridor.
Participants will be asked to walk as far as possible in 6 minutes at their own pace, with rest breaks permitted if needed.
Total distance walked will be recorded in meters.
This is a standardized, validated, and reproducible tool for assessing functional capacity and exercise tolerance in patients with heart failure.
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Baseline and 6 months after intervention start
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NYHA Functional Class
Tidsramme: Baseline and 6 months after intervention start
|
Heart failure severity classified according to the New York Heart Association (NYHA) functional classification system.
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Baseline and 6 months after intervention start
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Glycated Hemoglobin (HbA1c)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Measured using standard biochemical assay kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Fasting Blood Glucose
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample collected after at least 8 hours of fasting; fasting glucose measured using standard enzymatic glucose oxidase laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Body Mass Index (BMI)
Tidsramme: Baseline and 6 months after intervention start
|
Calculated as weight in kilograms divided by height in meters squared, using standardized stadiometer and scale.
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Baseline and 6 months after intervention start
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Quality of Life (QoL)
Tidsramme: Baseline and 6 months after intervention start
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Assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
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Baseline and 6 months after intervention start
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Systolic Blood Pressure
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.
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Baseline, end of month 2, end of month 4, and end of month 6
|
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Serum Amylase
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample; serum amylase measured using standard colorimetric enzymatic laboratory kit.
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Baseline, end of month 2, end of month 4, and end of month 6
|
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Alanine Aminotransferase (ALT)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample; serum ALT measured using standard enzymatic spectrophotometric laboratory kit.
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Baseline, end of month 2, end of month 4, and end of month 6
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N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Measured using human NT-proBNP ELISA kit.
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Baseline, end of month 2, end of month 4, and end of month 6
|
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Total Cholesterol
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample collected after at least 8 hours of fasting; total cholesterol measured using standard colorimetric enzymatic laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
|
Ejection Fraction
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Assessed by echocardiography.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Number of Participants With Gallbladder Problems
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Gallbladder problems (gallstones or cholecystitis) confirmed by abdominal ultrasound.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Number of Participants With Hypoglycemia
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Hypoglycemia, defined as blood glucose below 70 mg/dL, measured using standard enzymatic glucose oxidase laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Number of Participants With Injection Site Reactions
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Injection site reactions (including redness, swelling, itching, or pain at the injection site) assessed by physical examination.
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Baseline, end of month 2, end of month 4, and end of month 6
|
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Number of Participants With Gastrointestinal Adverse Events
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Gastrointestinal adverse events (including nausea, vomiting, diarrhea, constipation, or abdominal pain) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and assessed through participant interview and monitoring form.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
|
Number of Participants With Pancreatitis
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Pancreatitis diagnosed according to the revised Atlanta classification criteria, requiring at least two of the following: characteristic abdominal pain, serum amylase or lipase greater than three times the upper limit of normal, or characteristic findings on abdominal imaging.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
|
Number of Participants With Tachycardia
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Tachycardia, defined as a resting heart rate greater than 100 beats per minute measured by pulse oximetry or ECG monitoring at scheduled study visits.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Diastolic Blood Pressure
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
|
Serum Lipase
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample; serum lipase measured using standard colorimetric enzymatic laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Aspartate Aminotransferase (AST)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample; serum AST measured using standard enzymatic spectrophotometric laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Alkaline Phosphatase
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample; serum alkaline phosphatase measured using standard enzymatic spectrophotometric laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Low-Density Lipoprotein (LDL)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample collected after at least 8 hours of fasting; serum LDL measured using standard colorimetric enzymatic laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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High-Density Lipoprotein (HDL)
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample collected after at least 8 hours of fasting; serum HDL measured using standard colorimetric enzymatic laboratory kit.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Triglycerides
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Venous blood sample collected after at least 8 hours of fasting; serum triglycerides measured using standard colorimetric enzymatic laboratory kit at the central laboratory.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
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Pulmonary Artery Pressure
Tidsramme: Baseline, end of month 2, end of month 4, and end of month 6
|
Assessed by echocardiography.
|
Baseline, end of month 2, end of month 4, and end of month 6
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gene Expression of Obesity- and Heart Failure-Related Pathways
Tidsramme: Baseline and 6 months after intervention start
|
Venous blood sampling before the intervention and at the end of the study, extraction of ribonucleic acid from peripheral blood samples, and assessment of changes in the expression of genes involved in the shared molecular pathways of obesity and Heart Failure with Reduced Ejection Fraction using quantitative real-time polymerase chain reaction (PCR).
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Baseline and 6 months after intervention start
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hinney A, Nguyen TT, Scherag A, Friedel S, Bronner G, Muller TD, Grallert H, Illig T, Wichmann HE, Rief W, Schafer H, Hebebrand J. Genome wide association (GWA) study for early onset extreme obesity supports the role of fat mass and obesity associated gene (FTO) variants. PLoS One. 2007 Dec 26;2(12):e1361. doi: 10.1371/journal.pone.0001361.
- Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, Hovingh GK, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, Van der Meer P, von Lewinski D, Wolf D, Petrie MC; STEP-HFpEF Trial Committees and Investigators. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023 Sep 21;389(12):1069-1084. doi: 10.1056/NEJMoa2306963. Epub 2023 Aug 25.
- Klarin D, Natarajan P. Clinical utility of polygenic risk scores for coronary artery disease. Nat Rev Cardiol. 2022 May;19(5):291-301. doi: 10.1038/s41569-021-00638-w. Epub 2021 Nov 22.
- Mahley RW. Apolipoprotein E: cholesterol transport protein with expanding role in cell biology. Science. 1988 Apr 29;240(4852):622-30. doi: 10.1126/science.3283935.
- Kathiresan S, Melander O, Guiducci C, Surti A, Burtt NP, Rieder MJ, Cooper GM, Roos C, Voight BF, Havulinna AS, Wahlstrand B, Hedner T, Corella D, Tai ES, Ordovas JM, Berglund G, Vartiainen E, Jousilahti P, Hedblad B, Taskinen MR, Newton-Cheh C, Salomaa V, Peltonen L, Groop L, Altshuler DM, Orho-Melander M. Six new loci associated with blood low-density lipoprotein cholesterol, high-density lipoprotein cholesterol or triglycerides in humans. Nat Genet. 2008 Feb;40(2):189-97. doi: 10.1038/ng.75. Epub 2008 Jan 13.
- Wallner M, Biber ME, Stolfo D, Sinagra G, Benson L, Dahlstrom U, Gudbjornsdottir S, Cosentino F, Mol PGM, Rosano GMC, Butler J, Metra M, Lund LH, Ferrannini G, Savarese G. Glucagon-like peptide-1 receptor agonists use and associations with outcomes in heart failure and type 2 diabetes: data from the Swedish Heart Failure and Swedish National Diabetes Registries. Eur Heart J Cardiovasc Pharmacother. 2024 Jul 16;10(4):296-306. doi: 10.1093/ehjcvp/pvae026.
- Hankosky ER, Wang H, Neff LM, Kan H, Wang F, Ahmad NN, Griffin R, Stefanski A, Garvey WT. Tirzepatide reduces the predicted risk of atherosclerotic cardiovascular disease and improves cardiometabolic risk factors in adults with obesity or overweight: SURMOUNT-1 post hoc analysis. Diabetes Obes Metab. 2024 Jan;26(1):319-328. doi: 10.1111/dom.15318. Epub 2023 Nov 6.
- Borlaug BA, Zile MR, Kramer CM, Baum SJ, Hurt K, Litwin SE, Murakami M, Ou Y, Upadhyay N, Packer M. Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial. Nat Med. 2025 Feb;31(2):544-551. doi: 10.1038/s41591-024-03374-z. Epub 2024 Nov 17.
- Zile MR, Borlaug BA, Kramer CM, Baum SJ, Litwin SE, Menon V, Ou Y, Weerakkody GJ, Hurt KC, Kanu C, Murakami M, Packer M; SUMMIT Trial Study Group. Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity. Circulation. 2025 Mar 11;151(10):656-668. doi: 10.1161/CIRCULATIONAHA.124.072679. Epub 2024 Nov 18.
- Packer M, Zile MR, Kramer CM, Baum SJ, Litwin SE, Menon V, Ge J, Weerakkody GJ, Ou Y, Bunck MC, Hurt KC, Murakami M, Borlaug BA; SUMMIT Trial Study Group. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2025 Jan 30;392(5):427-437. doi: 10.1056/NEJMoa2410027. Epub 2024 Nov 16.
- Kosiborod MN, Verma S, Borlaug BA, Butler J, Davies MJ, Jon Jensen T, Rasmussen S, Erlang Marstrand P, Petrie MC, Shah SJ, Ito H, Schou M, Melenovsky V, Abhayaratna W, Kitzman DW; STEP-HFpEF Trial Committees and Investigators. Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial. Circulation. 2024 Jan 16;149(3):204-216. doi: 10.1161/CIRCULATIONAHA.123.067505. Epub 2023 Nov 12.
- Petrie MC, Borlaug BA, Butler J, Davies MJ, Kitzman DW, Shah SJ, Verma S, Jensen TJ, Einfeldt MN, Liisberg K, Perna E, Sharma K, Ezekowitz JA, Fu M, Melenovsky V, Ito H, Lelonek M, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program. J Am Coll Cardiol. 2024 Jul 2;84(1):27-40. doi: 10.1016/j.jacc.2024.04.022. Epub 2024 May 13.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
18. juli 2026
Primær færdiggørelse (Anslået)
11. juni 2027
Studieafslutning (Anslået)
22. december 2027
Datoer for studieregistrering
Først indsendt
27. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. juli 2026
Først opslået (Faktiske)
31. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Ernæringsforstyrrelser
- Hjertesygdomme
- Overernæring
- Kropsvægt
- Ændringer i kropsvægt
- Hjertefejl
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Vægttab
- Hjertesvigt, systolisk
- Aminosyrer, peptider og proteiner
- Proteiner
- Glucagon-lignende peptid-1-receptor
- Glucagon-lignende peptidreceptorer
- Receptorer, G-protein-koblet
- Receptorer, celleoverflade
- Membranproteiner
- Receptorer, gastrointestinal hormon
- Receptorer, peptid
- Tirzepatid
Andre undersøgelses-id-numre
- IRCT20200209046427N3
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .