Clinical trials: sponsored by UMC Utrecht
Mitral Regurgitation
Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Rationale: Severe asymptomatic organic Mitral Valve (MV) regurgitation with preserved left ventricular (LV) function is a challenging clinical entity as data on the recommended treatment strategy for these patients are scarce and…
- Trial name
- Dutch-AMR (NCT03975998)
- Testing
- Mitral valve repair
- Where
- 6 sites in Netherlands
- Volunteers
- 500 people
- Sponsor
- UMC Utrecht
Arthritis, Rheumatoid
REMission INDuction in Very Early Rheumatoid Arthritis
Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi) and methotrexate (MTX) often express their wish to stop MTX treatment because of side effects.
- Trial name
- REMINDRA (NCT02935387)
- Testing
- Taper
- Where
- 2 sites in Netherlands
- Volunteers
- 53 people
- Sponsor
- UMC Utrecht
Community-acquired Pneumonia
Increasing Community-acquired Pneumonia Protocol Adherence by Antibiotic Stewardship
The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.
- Trial name
- CAP-PACT (NCT02604628)
- Testing
- Antibiotic Stewardship Intervention
- Where
- 12 sites in Netherlands
- Volunteers
- 4,084 people
- Sponsor
- UMC Utrecht
Spinal Deformity, Spinal Instability
RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar spine, in terms of efficacy and safety.
- Conditions
- Spinal Deformity, Spinal Instability, Instrumented Spinal Fusion
- Trial name
- AxA (NCT01982045)
- Testing
- AttraX® Putty, Autologous bone graft
- Where
- 4 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- UMC Utrecht
in Vitro Fertilization, Ovulation Induction
Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)
Background of the study: Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates…
- Trial name
- LITE (NCT00823472)
- Testing
- Mild stimulation
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Chest Pain
Impact on Management of the HEART Risk Score in Chest Pain Patients
Aim of this study is to quantify the impact of the use of the HEART risk score on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to not using the score.
- Trial name
- HEART-Impact (NCT01756846)
- Testing
- usual care, use of HEART risk score
- Where
- 9 sites in Netherlands
- Volunteers
- 3,666 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Familial Dysbetalipoproteinemia, Hyperlipoproteinemia Type III
Effects of Evolocumab Versus Placebo Added to Standard Lipid-lowering Therapy on Fasting and Post Fat Load Lipids in Patients With Familial Dysbetalipoproteinemia
Patients with familial dysbetalipoproteinemia (FD) have increased triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), beta VLDL, premature atherosclerosis and cardiovascular disease.
- Trial name
- EVOLVE-FD (NCT03811223)
- Testing
- Evolocumab Auto-Injector [Repatha]
- Volunteers
- 30 people
- Sponsor
- UMC Utrecht
Perioperative Myocardial Infarction, Disability
Troponin Elevation After Major Noncardiac Surgery 2
Major adverse cardiac events (MACE) are a leading cause of mortality in patients undergoing noncardiac surgery. Patients with perioperative myocardial injury (PMI), defined as either myocardial infarction and lower elevations in…
- Conditions
- Perioperative Myocardial Infarction, Disability, Perioperative/Postoperative Complications
- Trial name
- TEAMS2 (NCT03408522)
- Where
- 3 sites in Canada, Netherlands
- Volunteers
- 1,000 people
- Sponsor
- UMC Utrecht
Foreign-Body Reaction, Inflammation
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.
Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis.
- Conditions
- Foreign-Body Reaction, Inflammation, Effusion (L) Knee, Knee Pain Swelling
- Trial name
- IMPACT (NCT02037204)
- Testing
- Cartilage repair surgery
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- UMC Utrecht
Prostate Cancer Adenocarcinoma
Hypofractionated Focal Lesion Ablative Microboost in prostatE Cancer
The hypo-FLAME study is a multicenter phase II study (n=100) to investigate whether a focal SBRT boost to the MRI-defined macroscopic tumor volume is feasible and associated with acceptable toxicity in addition to whole gland…
- Trial name
- Hypo-FLAME (NCT02853110)
- Testing
- Hypo-FLAME study
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 100 people
- Sponsor
- UMC Utrecht
Cardiovascular Diseases
Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension…
- Trial name
- POPCORn (NCT02616510)
- Testing
- cardiovascular screening
- Where
- Netherlands
- Volunteers
- 125 people
- Sponsor
- UMC Utrecht
Premature Ovarian Failure (POF), Incipient Ovarian Failure
Pheno- & Genotyping POF (WHO III)
This study focuses on the phenotyping and genotyping of women with hypergonadotropic ovarian dysfunction (WHO III status).
- Conditions
- Premature Ovarian Failure (POF), Incipient Ovarian Failure, Poor Response After Ovarian Hyperstimulation, Early Menopause
- Trial name
- NCT01411644
- Where
- Netherlands
- Volunteers
- 650 people
- Sponsor
- UMC Utrecht
Periprosthetic Aortic Valve Regurgitation After TAVI
Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic Valve Implantation
Transcatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery.
- Trial name
- ELECT (NCT01982032)
- Testing
- Transcatheter aortic valve replacement, Medtronic CoreValve system, Edwards SAPIEN bioprosthesis
- Where
- Netherlands
- Volunteers
- 56 people
- Sponsor
- UMC Utrecht
Cardiovascular Diseases
Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients
A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 279 patients at risk for cardiovascular…
- Trial name
- NCT02725203
- Testing
- Activate
- Where
- 31 sites in Netherlands
- Volunteers
- 195 people
- Sponsor
- UMC Utrecht
Coronary Stenosis, Myocardial Ischemia
Application of speCtraL Computed tomogrAphy to impRove specIficity of Cardiac compuTed tomographY
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for…
- Conditions
- Coronary Stenosis, Myocardial Ischemia, Cardiovascular Diseases
- Trial name
- CLARITY (NCT03139006)
- Testing
- Dual-layer spectral detector CT
- Where
- Netherlands
- Volunteers
- 75 people
- Sponsor
- UMC Utrecht
Radioisotopes, Head and Neck Neoplasms
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors
The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.
- Trial name
- HIT (NCT02975739)
- Testing
- Holmium-166 (poly L lactic acid) microspheres
- Where
- Netherlands
- Volunteers
- 1 people
- Sponsor
- UMC Utrecht
Breast Neoplasm
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
- Trial name
- ABLATIVE (NCT02316561)
- Testing
- Single dose ablative radiotherapy
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- UMC Utrecht
Congestive Heart Failure
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM).
- Trial name
- REMOTE-CIED (NCT01691586)
- Testing
- Remote patient monitoring, In-Clinic check-ups
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- UMC Utrecht
Stable Angina Pectoris, Acute Coronary Syndrome
Randomized "All-comer" Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent
The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population.
- Trial name
- NCT02328898
- Testing
- Cre8 Stent, Resolute Integrity stent
- Where
- 3 sites in Luxembourg, Netherlands
- Volunteers
- 1,532 people
- Sponsor
- UMC Utrecht
Multiple Trauma, Sepsis
The Role of Post-traumatic Inhibition of the Innate and Adaptive Immune System in the Development of Infectious Complications in Severely Injured Patients
Patients admitted to the Intensive Care Unit after severe injury are prone to suffer from infectious complications and even sepsis.
- Conditions
- Multiple Trauma, Sepsis, Innate Immune Response, Disorder of Neutrophils
- Trial name
- POSEIDON (NCT03489577)
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- UMC Utrecht